WHO WE ARE

WHAT WE DO

WHY WE CARE

EMPLOYEE BENEFITS

LATEST JOBS

WHO WE ARE

Wall Street Consulting Services is a leading IT solutions company. We work with some of the biggest companies in the world to help them achieve the next level of success. Our diligent approach and cutting edge solutions have made us the partner of choice for organisations seeking IT services.

WHO WE ARE

Wall Street Consulting Services is a leading IT solutions company. We work with some of the biggest companies in the world to help them achieve the next level of success. Our diligent approach and cutting edge solutions have made us the partner of choice for organisations seeking IT services.

WHAT WE DO

We provide a full suite of IT transformation services starting from whole organisation endeavours such as BPM to siloed solutions like CRM and Custom development. We are also in the recruitment and staffing business and help our clients with a variety of talent solutions.

WHY WE CARE

Individually and collectively, we impact thousands of people through our products and services every day. We work alongside some of the most talented and innovative clients doing their part in making a difference to the world and we value our employees who play a vital role in ensuring we deliver such outcomes.

WHY WE CARE

Individually and collectively, we impact thousands of people through our products and services every day. We work alongside some of the most talented and innovative clients doing their part in making a difference to the world and we value our employees who play a vital role in ensuring we deliver such outcomes.

EMPLOYEE BENEFITS

Employee events

WSCS conducts events where our employees get to interact with each other, engage in fun activities and get an opportunity to understand the company better.

 

Employee events

WSCS conducts events where our employees get to interact with each other, engage in fun activities and get an opportunity to understand the company better.

Training and Development

We offer training programs to our employees that are designed to aid their development and help them reach their full potential and take on higher job roles within the company.

Training and Development

We offer training programs to our employees that are designed to aid their development and help them reach their full potential and take on higher job roles within the company.

Employee Benefits

We value our employees’ time and efforts and reciprocate our appreciation through various programs that benefit their financial, medical and overall health and well being.

Employee Benefits

We value our employees’ time and efforts and reciprocate our appreciation through various programs that benefit their financial, medical and overall health and well being.

Company Culture

Our culture is an amalgamation of teamwork, respect, work-life balance and employee-first HR policies that lead the way for our values and behaviour within the company.

Company Culture

Our culture is an amalgamation of teamwork, respect, work-life balance and employee-first HR policies that lead the way for our values and behaviour within the company.

EMPLOYEE EVENTS

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LATEST JOBS

LATEST JOBS

Job Name

Job Category

Location

Action

Systems Analyst and Software Engineers

Systems Analyst and Software Engineers

Princeton, NJ USA

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Software Engineers

Software Engineers

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Software Engineers

Software Engineers

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Validation Lead

Validation Lead

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Validation Engineer

Validation Engineer

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Supply Chain Tech

Supply Chain Tech

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Supplier Quality Engineer

Supplier Quality Engineer

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Senior Quality Engineer

Senior Quality Engineer

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Senior Electrical Engineer

Senior Electrical Engineer

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Regulatory Affairs

Regulatory Affairs

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R&D Design Engineer

R&D Design Engineer

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Quality Engineer

Quality Engineer

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Quality Engineer III

Quality Engineer III

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Quality Engineer I

Quality Engineer I

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Quality Assurance

Quality Assurance

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Product Development Engineer

Product Development Engineer

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Process Engineer

Process Engineer

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Medical Writer III

Medical Writer III

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Medical Devices Systems Engineer

Medical Devices Systems Engineer

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Manufacturing Engineer

Manufacturing Engineer

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Engineer III

Engineer III

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Electrical Engineer

Electrical Engineer

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Clinical Research Coordinator

Clinical Research Coordinator

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CAPA Engineer

CAPA Engineer

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CRM Consultant

CRM Consultant

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Big Data Analyst

Big Data Analyst

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Security Architect

Security Architect

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.Net Developer

.Net Developer

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Full-Stack Developer

Full-Stack Developer

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Java Developer

Java Developer

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UI/UX Designer

UI/UX Designer

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UI/UX Developer

UI/UX Developer

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Web Developer

Web Developer

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1-609-666-2636

info@wallstreetcs.com

Office Location:
New Jersey & Georgia

Facebook Instagram Linkedin

1-609-666-2636

info@wallstreetcs.com

USA

  • info@wallstreetcs.com
  • Office Locations:
    New Jersey & Georgia
  • 1-609-666-2636
Facebook Instagram Linkedin

1-609-666-2636

info@wallstreetcs.com

Office Location:
New Jersey & Georgia

Facebook Instagram Linkedin

1-609-666-2636

info@wallstreetcs.com

USA

  • info@wallstreetcs.com
  • Office Locations:
    New Jersey & Georgia
  • 1-609-666-2636
Facebook Instagram Linkedin

1-609-666-2636

info@wallstreetcs.com

Social Media

Facebook Instagram Linkedin

USA

  • info@wallstreetcs.com
  • 1-609-666-2636
Facebook Instagram Linkedin

Systems Analyst and Software Engineers

Job Category:

Systems Analyst and Software Engineers​

Job Location:

Princeton, NJ USA

Experience required:

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Wall Street Consulting Services LLC has multiple openings in Princeton, NJ and other unanticipated locations nationwide for computer professionals such as Systems Analysts and Software Engineers with at least 3 years of experience in certain combinations of the following skills:

CRM, .Net, C#, TCP/IP, Kubernetes, YAML, CRM SDK, Microsoft Dynamics, jQuery, Ajax, CSS, Azure, WPF, MVC, LINQ, Web API, Agile and Waterfall Methodologies of software development, c#, Microsoft Dynamics CRM, .NET Framework, SQL Server, Oracle, T-SQL.

All positions require a Masters Degree or the equivalent. A baccalaureate degree with 5 years of post-baccalaureate, progressive experience is acceptable for Master’s equivalency. Any suitable combination of education, training, or experience is acceptable. Travel/relocation may be required. Mail two copies of resume and proof of work eligibility to: 100 Overlook Center, 2nd Floor, Princeton, NJ 08540.

Apply For This Position

SOFTWARE ENGINEERS

Job Category:

Software Engineers

Job Location:

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Experience required:

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Wall Street Consulting Services LLC has positions available for Software Engineers in Princeton, NJ and other unanticipated locations nationwide.

Duties: Design, develop, create, modify, customize, test, and validate software
applications using C#, .Net, C++, XML, ASP, ASP.Net, NHibernate, MVC,
SQL Server, Web Services, JavaScript, XSD, XSLT and WCF.

Send resume/w proof of work eligibility to: HR- Wall Street Consulting Services LLC, 100 Overlook Center, 2nd Floor, Princeton, NJ 08540.

 

  • Master’s degree or equivalent in Computer Engineering, Electrical Engineering or related field with at least one (1) year of experience in job offered or related occupation such as Software Developer.
  • Any suitable combination of education, training or experience is acceptable. Travel/relocation may be required.
 
 

Apply For This Position

Validation Lead

Job Category:

Validation Lead

Job Location:

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Experience required:

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  • Experienced in Software Validation – GAMP 5 (pharma or medical device experience preferred)
  • Experience validating SAP, preferred
  • MS Project/ Office365 skills are a must

Apply For This Position

Validation Engineer

Job Category:

Validation Engineer

Job Location:

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Experience required:

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  • Review of process validations for identification of gaps to internal and external requirements.
  • Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures and Instructions.
  • This Engineering position will work within the client’s Production Engineering – Process Validation team.
  • Department and with other functional groups, as needed, to identify process validation needs.
  • Demonstrate the understanding of medical device regulations and best practices Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk management (ISO 14971).
  • Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools.

Apply For This Position

Supply Chain Tech

Job Category:

Supply Chain Tech

Job Location:

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Experience required:

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The Supplier Quality Engineer is responsible for driving exceptional supplier performance to create a world-class supply base that exceeds expectations for the business group and the global Supply Chain team. Specific focus will be supplier analysis, development activities, technical support, part qualifications, improvement activities, corrective actions, and new product introductions to ensure component parts and assemblies are consistently manufactured in total compliance to specified requirements. Simultaneously and in conjunction with the Strategic Purchasing Group this position will support the balanced improvement of quality, cost and service, all while operating within Nordson’s Lean manufacturing principals.

  • As a Supply Chain Tech, you will work directly in our facilities receiving and distributing supplies. Our Supply Chain team is dedicated to providing the materials needed to ensure quality care can be delivered to our patients.
  • Process all “returns to vendor” or “returns to backup stock” and deliver supplies in an accurate and timely manner
  • Transport and deliver legend drugs, non-prescription drugs, contrast media and drug-containing devices
  • Receive expedited deliveries, accurately key receiving into the SMART system, and deliver to appropriate department
  • Receive all cross-docked items into the SMART system
  • Review and maintain Min/Max for storeroom safety stock daily and place orders appropriately
  • Count par level areas (POU areas) weekly according to schedule
  • Ensure POU items have the appropriate barcodes
  • Perform QA random checks on totes
  • Rotate stock in POU areas and backup storeroom areas to ensure no items are out of date and provide assistance to personnel
  • Check after-hour logs for charges and determine how to avoid reoccurrence
  • High school diploma or GED is required
  • Previous stock clerk or customer service experience preferred

Apply For This Position

Supplier Quality Engineer

Job Category:

Supplier Quality Engineer

Job Location:

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Experience required:

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The Supplier Quality Engineer is responsible for driving exceptional supplier performance to create a world-class supply base that exceeds expectations for the business group and the global Supply Chain team. Specific focus will be supplier analysis, development activities, technical support, part qualifications, improvement activities, corrective actions, and new product introductions to ensure component parts and assemblies are consistently manufactured in total compliance to specified requirements. Simultaneously and in conjunction with the Strategic Purchasing Group this position will support the balanced improvement of quality, cost and service, all while operating within Nordson’s Lean manufacturing principals.

  • Track the supplier’s performance indicators, based on their scorecards and rankings, to facilitate and develop the supply base’s ability to consistently meet or exceed our defined expectations.
  • Routinely provide performance communication to the supply base and internal personnel to insure the proper use of suppliers based on performance.
  • Develop the supplier’s ability to support Nordson’s Lean manufacturing principles and problem avoidance processes through the use of best in class quality, delivery and lead-time performance processes.
  • Drive a systematic problem solving and process improvement approach utilizing Lean Six Sigma principles.
  • Function as a technical liaison between suppliers, engineering, SCM group, business group, and manufacturing sites, to resolve supplier related issues.
  • Assure supplier’s corrective and preventive action plans are developed and executed in compliance with Nordson expectations. Report on the status of corrective actions, as required, to manufacturing, business group and executive management.
  • Perform supplier on-site assessments and assistance visits for supplier selection, to improve supplier performance, and achieve Nordson’s balanced improvement objectives.
  • Develop and implement (APQP) Advanced Product Quality Planning for new and existing purchase parts.
  • Review supplier processes, collaborate with suppliers on process improvement, and value enhancement opportunities.
  • Support and utilize the Strategic Group’s activities and direction on supplier development, risk management, reduction and consolidation.
  • Promote early supplier involvement at project development stages.
  • Support and coordinate with the Business Unit’s new product activities and direction to better ensure component manufacturability, more than satisfactory and sustainable quality performance for every component, particularly critical components, during the transition from new product development to production.
  • Other duties as assigned.

Apply For This Position

Senior Quality Engineer

Job Category:

Senior Quality Engineer

Job Location:

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Experience required:

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Experience with process improvement
Experience with launching new mftg line/site

  • Supporting manufacturing process – Equipment Implementation/SOPs, Work Instructions, Process Improvement
  • Executing changes in regulatory/quality system and launching on manufacturing line
  • Bachelors Degree Required
  • 4+ years of relevant experience
  • Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
  • Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
  • Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
  • Adapts machine or equipment design to factory and production conditions.
  • May incorporate inspection and test requirements into the production plan.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control and may be asked to develop those techniques.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.
  • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Apply For This Position

Senior Electrical Engineer

Job Category:

Senior Electrical Engineer

Job Location:

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Experience required:

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  • Contribute to cross-functional engineering efforts for a complex, software-controlled electro-mechanical medical device comprised of capital equipment and disposables
  • Responsible for designing and rapid prototyping concepts and iterating through the design process
  • Ensure compliance with Design Control regulations, including, but not limited to, specification development, risk analysis, design reviews and verification and validation protocols and reports
  • Responsible for writing electrical subsystem verification test protocols and reports
  • Design and develop PCBA functional test fixtures – LabView experience a plus
  • Prepare and execute EMC test plans
  • Provide direct support to contract manufacturers for supply of PCB assemblies and PCB-level components
  • Generate and through formal change order processes, maintain schematic, PCB and PCBA documents
  • Create written specifications and functional description documents
  • Prepare for and lead electrical design reviews, and contribute to system-level design reviews
  • Work collaboratively with external design services
  • Address field issues by determining root cause and implementing corrective actions as necessary
  • 8 to 10 years of experience performing circuit design and PCB layout for complex electro-mechanical medical devices
  • BS in Electrical Engineering, advanced degree preferred
  • Circuit design experience to Include microprocessor, analog, digital, motion control, power supplies and battery power management
  • OrCAD Capture & Allegro PCB Designer experience strongly preferred
  • Successful track record of working in high-growth and dynamic organizations
  • Understanding of medical device development processes including experience with FDA CFR 820 and ISO 13485 regulations
  • Skilled at reworking PCB assemblies while performing soldering/de-soldering of fine pitch PCB components
  • At TransMedics, we care about people—and that includes our employees. We know our employees are key to our success and the success of our patients. We offer an engaging, supportive work environment, great benefits, and the opportunity to shape both our future and the future of transplant medicine.
  • TransMedics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

Apply For This Position

Regulatory Affairs

Job Category:

Regulatory Affairs

Job Location:

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Experience required:

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  • Maintains MMQCI’s ISO 13485 certification and prepares input into Technical Files for CE marking of MMQCI products and maintains international product registrations.
  • Prepares and submits FDA pre-submissions, and 510(k) submissions and maintains appropriate FDA registrations.
  • Interprets statutes, regulations, policies and guidance for MMQCI staff teams, communicating how these impact product development, manufacturing, and/or marketing.
  • Remains current on regulatory issues/trends affecting MMQCI products, assessing and communicating their impact to QA/RA colleagues and support teams.
  • Provides training or presentations to cross-functional groups on a variety of regulatory topics.
  • Reviews and approves all MMQCI Quality System documentation to ensure compliance with established procedures and regulatory compliance requirements, including, but not limited to, Master Batch Records, Standard Operating Procedures (SOPs), Change Orders, Material Review Notices (MRNs) and Corrective and Preventive Actions (CAPAs). Works closely with all departments to investigate MRNs and establish CAPAs addressing root cause.
  • Participates in, and may conduct, internal, customer, FDA, and ISO audits.
  • MMQCI staff to review and approve product labeling changes, promotional literature and marketing materials, rework of non-conforming product, CAPA closures, Customer Complaint closures, and Medical Device Reports (MDR).
  • Writes SOPs and trains key personnel as needed.
  • Performs other duties as assigned.
  • Education Requirements: Bachelor of Science degree in Life Sciences and at least 5 years of employment in a cGMP regulated facility and at least 2 years of experience in Quality Assurance.
  • Excellent proof-reading skills are required.
  • Knowledge of current GMP regulation, ISO 13485, and In Vitro Diagnostic Regulation (IVDR) is required.
  • Experience in laboratory medicine is highly preferred.
  • Good communication skills, written and oral, with excellent computer skills. Strong work ethic with the ability to work in a dynamic environment with changing priorities.
  • Ability to meet challenging timelines, in spite of obstacles.
  • Willingness to learn and pitch in as part of team.
  • Ability to communicate clearly and constructively to correct non-conforming behaviors and practices.
  • Must be a nonsmoker due to product contamination prevention requirements.

Apply For This Position

R&D Design Engineer

Job Category:

R&D Design Engineer

Job Location:

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Experience required:

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Design products, prototypes, equipment or fixtures for medical device applications.
Operate processing equipment in a specific process area, including but not limited to mechanical testing equipment and machining support equipment.
Design experiments to provide data based conclusion about a process or product performance.
Perform/coordinate characterization testing as needed for part characterization (ex. mechanical testing) and communicate results to project stakeholders.
Procure and implement new testing and manufacturing equipment using IQ/OQ/PQ validation techniques.
Conduct/support process development activities.
Assist in project tasks planning, management, coordination and execution.
Using GDP practices, maintain laboratory notebook and write technical reports detailing procedures, outcomes, and observations.
Assist in creation of publishable research findings in the form of abstracts, papers and grants.
Recommend and rationalize specifications for development products.
Support patent filing and claims.
Interface with cross-functional team members to develop specifications, coordinate prototype fabrication, and transition medical device prototypes into manufactured components.

  • Prior experience with medical and/or pharmaceutical grade materials preferred, especially bioabsorbable/bioresorbable materials.
  • Prior experience with polymeric synthesis techniques and associated equipment.
  • Prior experience with polymer processing and associated equipment (extrusion, solvent casting, dip coating, mixing, etc.)
  • Prior experience with material characterization analytical techniques as inputs for process development and characterization (UV VIS, NMR, FTIR, GC, rheology, GPC, HPLC etc.).
  • Prior experience with prototype characterization techniques (surface profilometry, microscopy, 3D scanning, etc.).
  • Prior hands-on experience with mechanical testing equipment, fixture design, and test method execution.
  • Prior hands-on experience with 3D CAD design software (including, but not limited to, SOLIDWORKS).
  • Prior experience in 3D printer operation, tuning, and maintenance (VP, FFF, etc.)
  • Prior experience with cell culture and associated in vitro analysis techniques.
  • Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
  • Prior experience with performing test methods in accordance with USP, FDA, ISO and/or ASTM standards.
  • Ability to handle confidential business information.
  • Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab.
  • Understanding of cause-effect relationship between process inputs and product specifications.
  • Understanding of the effect of a process on downstream steps or customer needs.
  • Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.
  • Good written and verbal communication skills, particularly for team communications.

Apply For This Position

Quality Engineer

Job Category:

Quality Engineer

Job Location:

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Experience required:

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Local CT medical device company, looking for a junior quality engineer with good co-op experience and 2-3 years experience dealing with medical device.

  • BS Experience level: 2 years 3 years

8 hour shift

Apply For This Position

Quality Engineer III

Job Category:

Quality Engineer III

Job Location:

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Experience required:

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Adheres to Core Beliefs and all safety and quality requirements including, but not limited to:

  • Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
  • Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
  • Monitors manufacturing of assigned products, assuring compliance with DMR while providing deviation/waiver guidance and assuring complete and correct Device History Records are maintained.
  • Leads and implements various product and process improvement methodologies.
  • Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
  • Leads in the completion and maintenance of risk analysis.
  • Leads generation and completion of protocols and reports for test method validations.
  • Interfaces with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommends process monitoring devices where applicable.
  • Develops various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
  • Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
  • Effectively communicate and interact with customers.
  • Leads and manage complaint investigations.
  • Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
  • Assists with product transfers.
  • Works with suppliers, management, Engineers and Manufacturing associates in the resolution of quality problems. Also, leads each of these groups with capability studies and the application of statistical quality control which include Cpk, DOE, Hypotheses Testing, etc.
  • Coordinates and leads the preparation of Quality Plans, including inspection, test and gauge requirements for new product introductions.
  • Provides support to other quality engineers.

Bachelor’s Degree in Engineering or related field required or 7-10 years of experience working in a quality engineering role within a regulated industry.

 

Apply For This Position

Quality Engineer I

Job Category:

Quality Engineer I

Job Location:

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Experience required:

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  • Consult with Manufacturing, Information Management, Research Development & Engineering,
    Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations.
  • Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis.
  • Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs.
  • Occasionally provide training for select software development activities for LifeScan.
  • Occasionally write and execute test protocols and reports.

Apply For This Position

Quality Assurance

Job Category:

Quality Assurance

Job Location:

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Experience required:

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We are looking for a detail-oriented quality assurance specialist to be in charge of all quality assurance activities. The quality assurance specialist’s responsibilities include developing and implementing quality assurance policies, conducting tests and inspections, identifying production, process, or product issues, and presenting solutions.

To be successful as a quality assurance specialist you should be incredibly thorough and able to help our company maintain the highest quality standards.

Apply For This Position

Product Development Engineer

Job Category:

Product Development Engineer

Job Location:

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Experience required:

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  • Design/develop implants and instruments and build a strong Design History file for each product.
  • Daily communication cross-functionally and with stakeholders.
  • Utilize design controls per Quality Management System.
  • Work closely with manufacturing and quality to solve issues before, during and after production.
  • Provide design for manufacturability feedback to customers and affiliates.
  • Innovate origiinal product design concepts.
  • Implement product design changes as needed; provide suggestions for same.
  • Communicate/meet with clients (surgeons, industry representatives) as needed.
  • Maintain good documentation (ISO 13485, FDA, Etc) of all Development activities.
  • Attend inter-company and external meetings as required.
  • National/international travel as required – estimated 5% – 20%.
  • Bachelor’s degree in Engineering or equivalent experience in Engineering Manufacturing Technology or related field preferred. Mechanical, biomedical or biomedical engineering preferred.
  • 3+ years of experience in engineering or manufacturing process development required; 2+ years of experience in Quality or Manufacturing Engineering preferred; 1+ years of experience in Quality or Manufacturing Engineering required; 1+ years of experience using ERP software required; 1+ years of experience using LabVIEW required; 1+ years of experience using Microsoft Office required; 1+ years of experience using CAD software preferred; Strong analytical skills; basic GD&T, Strong problem solving skills; Strong communication skills; Strong organizational skills; Strong time management skills; Strong critical thinking skills; Strong problem solving skills; Strong ability to work well under pressure; Strong attention to detail required; Excellent communication skills required; Excellent written and verbal skills preferred; Experience with ERP systems preferred (e.g., ERP systems: NetSuite, MS Dynamics 365, Microsoft Dynamics 365 preferred); Experience with Material Handling Systems preferred (e.g., Material Handling Systems: Material Handling Equipment: Forklifts, Scissor Tractors, Palletizers); Experience with ERP software preferred (NetSuite); Knowledge of Lean Manufacturing preferred (Shelterline); Knowledge of Lean Manufacturing preferred (Shelterline); Knowledge of Lean Manufacturing preferred (Shelterline); Knowledge of Lean Manufacturing preferred (Shelterline).

Apply For This Position

Process Engineer

Job Category:

Process Engineer

Job Location:

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Experience required:

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  • Develop manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
  • Perform equipment qualifications (IQ), process validations (Process characterization, OQ and PQ), and gage R&R studies (TMV).
  • Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
  • Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Review product development requirements for compatibility with processing methods to determine costs and schedules.
  • Interact with product design and development personnel to ensure that processes and designs are compatible.
  • Generate and maintain documentation per quality system regulations.
  • Ensure processes and procedures are in compliance with regulations.
  • Medical device/Pharmaceutical or other regulated industry experience.
  • Hands on experience with process and/or equipment development on manufacturing process.
  • Experience with DRM / DFSS, Lean Sigma, or Green/Black Belt Lean Sigma certification.
  • Knowledge of DOE, statistical analysis methods and data analysis tools (Minitab, JMP, etc.).
  • Experience and understanding of SPC principles including process capability analysis and control charts.
  • Experience or aptitude to program, run and troubleshoot automated assembly equipment, visual inspection, or automated metrology tools.

Apply For This Position

Medical Writer III

Job Category:

Medical Writer III

Job Location:

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Experience required:

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  • Write clinical evaluation reports (CERs) and post market surveillance summaries.
  • Work with internal teams to gain cross-functional inputs and approvals.
  • Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
  • Develop and manage CER project plans and timelines.
  • Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
  • Perform comprehensive literature searches to support assigned product lines.
  • Consistently apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures.
  • Assist in development of processes Collect and maintain all documents necessary to ensure compliance with SOP.
  • Minimum 2 years medical writing experience preferred.
  • Proven experience performing literature reviews, analyzing data and communicating outputs.
  • Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
  • Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
  • Demonstrated ability to build positive constructive relationships with cross-functional team members.
  • Demonstrated high level of personal integrity, emotional intelligence, flexibility Knowledge of MDD, MDR and MEDDEV requirements.
  • Proficient scientific writing skills.
  • Experience creating and performing literature searches in Embase, PubMed and Google Scholar.
  • Experience using Microsoft Word, Excel, PowerPoint.
  • Strong data extraction and analysis skills.
  • Proactive with a sense of urgency in managing job responsibilities.
  • Self-motivated and able to work independently.
  • Analytical thinking and inquisitive mindset Ability and desire to develop good working relationships internally and externally.
  • Bachelors in a relevant discipline required. Master’s degree or PhD preferred.

Apply For This Position

Medical Devices Systems Engineer

Job Category:

Medical Devices Systems Engineer

Job Location:

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Experience required:

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  • Systems Design and Development: Lead the design and development of systems within medical devices, ensuring they meet performance, safety, and regulatory requirements.
  • Requirement Management: Define, document, and manage system requirements, ensuring alignment with customer needs, regulatory standards, and product specifications.
  • Identify and assess risks associated with the medical device system, implementing strategies to mitigate them and ensuring compliance with risk management standards.

Apply For This Position

Manufacturing Engineer

Job Category:

Manufacturing Engineer

Job Location:

---

Experience required:

---

Responsibilities:

  • Identify opportunities for equipment, process and yield improvements.
  • Qualify processes and tooling via IQ/OQ/PQ process capability studies, Gage R&R studies and design of experiment (DOE).
  • Provide problem solving for manufacturing issues including root cause, containment and corrective preventive actions.
  • Design and fabricate manufacturing tools and fixtures.
  • Effectively communicate both verbally and in writing.
  • Liaise with R&D to integrate new processes and equipment into the manufacturing environment.
  • Ability to prioritize day to day activities balancing immediate needs with long term project goals.
  • Create manufacturing and process documentation.
  • Must have, min. 3 years’ engineering experience in the Medical Device Industry.
  • Proficient command of SolidWorks.
  • Machine Shop experience including manual lathe and milling machines.
  • Experienced in tool and fixture design.
  • Demonstrated experience qualifying processes and tooling via IQ/OQ/PQ process capability studies, Gage R&R studies and design of experiment (DOE).

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Engineer III

Job Category:

Engineer III

Job Location:

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Experience required:

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Position Summary:

  • The Validation Engineer will be involved in preparing and implementing.
  • Installation/Operation/Performance qualification (IQOQPQ) protocols and other validation study protocols.
  • 4Maintaining the validation schedule and keeping all equipment and processes in a qualified state to support GMP requirements.
  • Preparation and execution of validation protocols (equipment, facility, cleaning, Spreadsheet Validation and computerized systems).
  • Assisting system owners with impact assessments and identifying qualification/validation requirements.
  • Carrying out all validation activities on equipment before handover/return to system owner and updating all relevant records and schedules.
  • Arranging Field Service Engineer to qualify equipment / instruments.
  • Maintaining validation equipment in a state of calibration and compliance to support the company’s validation efforts and support review and approvals of the OOT.
  • Effectively present the validation program in customer audits and regulatory inspections.
  • Creating/maintaining qualification related records, procedures, documents and drawings.
  • Ensuring compliance with safety, health and environmental (SHE) legislation.
  • Engaging with project teams to help with selection, installation and commissioning of new equipment.
  • At least 3 years validation experience within a GMP environment.
  • Demonstrable validation experience in a medical device ISO13485, biopharmaceutical (chromatography, ELISA), consumer healthcare or related industry.
  • Demonstrated understanding of validation requirements for international markets including (but not limited to) FDA and EMA.
  • Knowledge of commissioning and equipment validation to include autoclaves, temperature controlled storage and automated production lines, cleaning validation experience.
  • Proven problem solving skills/diagnosing faults/resolving qualification issues.
  • Excellent planning and time management ability.
  • The ability to work independently and autonomously to support validation projects and communicate progress and any issues via team meetings and project meetings.
  • Demonstrated effective interpersonal skills with an ability to interface effectively at all levels.

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Electrical Engineer

Job Category:

Electrical Engineer

Job Location:

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Experience required:

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The Electrical Engineer designs, develops, modifies, and evaluates components and processes used in the generation, manipulation, transmission, and storage of electricity. This individual determines design approaches and parameters; Analyzes equipment to establish operating data, conducts experimental tests, and evaluates results. Selects components and equipment based on analysis of specifications and reliability. Completes documentation and procedures for installation and maintenance. May interact with users to define system requirements and/or necessary modifications.

  • Develop thorough understanding of our products and their use in clinical practice to design, develop and test our next generation diagnostic systems.
    Works collaboratively with other team members and functions such as program management, field service, manufacturing, mechanical, compliance, reliability, or design engineers.
  • Participate in or lead project activities such as component analysis and testing, the design, analysis, or troubleshooting of printed circuit assemblies, cable and harnessing design, power distribution, and assisting manufacturing or service to solve problems.
  • Contributor in the design process, including Design Transfer activities from R&D to sustaining.
  • Integrates electronics and automation into products, including mechanics, electro-optical, software, and user interface.
  • Specifies, evaluates, and selects electronic and electromechanical components.
  • Develops, builds, and maintains electrical test fixtures, test control apparatus, and equipment and determines methods, procedures, and conditions for testing the engineered products and associated apparatus.
  • Responsible for creating supporting documentation such as CAD package updates, design requirements, specifications, verification procedures or reports, and engineering change notices.
  • Ensures design, fabrication, maintenance, and repair methods/processes are developed and executed in a manner that supports all quality standards.
  • Develops, verifies, and validates processes for manufacturing. Ensures manufacturing, construction, installation, and operational testing conforms to functional specifications and customer requirements.
  • Actively supports and adheres to the Quality Policy and Quality System procedures.
  • Identify meaningful improvements positively impacting product quality and manufacturing efficiency. Contributes to CAPA, VIP, cost reduction, EOL and other projects.
  • Establish collaborative relationships with all stakeholders within the division.
  • Continue professional development by channeling interests and development needs and seeking opportunities to learn and grow within the company.
  • Manage several projects and priorities concurrently, under more senior Engineer supervision, as defined by program or functional management.
  • Proficient in MS Office. Knowledge of at least one CAD tool suite for PCB design.
  • Understanding of electronic design, medical device design, analog/digital circuit design, PCB design, PCB and PCBA manufacturing processes, software, optics, and human factors.
  • Ability to design at a moderate complexity level; Ability to test systems and subsystems in both analog and digital electronics; Ability to understand, troubleshoot, and resolve issues with equipment and processes; Ability to test and debug moderate complexity electronic designs to a component level; Ability to perform hands-on fabrication, testing, and repair work.
  • Familiarity with laboratory test equipment such as multi-meters, oscilloscopes, spectrum analyzers, function generators, logic analyzers, etc.
  • Knowledge of IEC 60601-1 and 60601-1-2 technical standards.
  • Ability to work in a team environment and collaborate with technical and non-technical audiences.
  • Strong written and verbal communication and interpersonal skills.
  • Skilled in reading and interpreting mechanical drawings.
  • Understanding of revision control for design and documentation.
  • Ability to create Standard Operating Procedural Documentation.
  • Demonstrates logical thinking with a strong ability to analyze statistical data.
  • Understanding of Design for Manufacturability (DFM), Root Cause, Root Cause Failure Analysis Methodologies, Failure Mode and Effect Analysis (FMEA).
  • The ability to lead corrective actions is beneficial.
  • Lean Six Sigma Yellow Belt is beneficial.
  • The ability to write embedded code to test designs is beneficial.
  • Preferred Minimum Non-Technical Degree: College Degree.
  • Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree.
  • Preferred Minimum Non-Technical Degree: 2-5 Years.
  • Preferred Minimum Technical/Advanced Degree: 1-2 Years with Technical Bachelor’s Degree, 0-2 Years with Master’s Degree.
  • Experience in an FDA regulated medical device industry is beneficial.

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Clinical Research Coordinator

Job Category:

Clinical Research Coordinator

Job Location:

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Experience required:

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  • The CRC II is responsible for managing and conducting clinical trials at a clinical site in a manner which is in accordance to the study protocol, standard operating procedures (SOPs), ICH-GCP, HIPAA, IATA and other regulatory guidelines that apply to clinical research.
  • Proactively manages and leads a clinical site in conducting clinical research.
  • Independently maintain correspondence with the IRB such as safety reporting, annual renewals, and other IRB submissions.
  • Works with investigator to find potential subjects per protocol eligibility. Schedules study visits and information sessions with subjects.
  • Enrolls subjects by properly assessing eligibility criteria, consenting individuals, and obtaining other authorizations in a manner consistent with safety and quality standards as recommended by ICH guidelines, SOPs, and the study protocol.
  • Conducts protocol related study visits and procedures as delegated by investigator such as EKGs, phlebotomy, IP accountability, etc.
  • Maintains and ensures quality source and regulatory documentation throughout the clinical trial.
  • Monitors health and safety of subjects by following up with study participant’s medical providers, obtaining relevant medical records, documenting adverse and serious adverse events, and presenting them to the Investigator or Sponsor where appropriate.
  • Creates and maintains databases of subject information, electronic source documentation, and electronic regulatory binders through the various components of the electronic data management system.
  • Prepares documents for review by sponsors, monitors and regulatory authorities, as necessary.
  • Independently manages correspondence with sponsors, monitors and regulatory authorities, including monitoring visits.
  • Undergraduate Degree required.
  • At least 1.5 years experience in clinical research required.
  • Prior Phlebotomy experience required.
  • Proficiency in using computerized systems such as Microsoft applications, CTMS, IWRS, EDC, and other vendor systems used in clinical research.
  • Understanding of ICH-GCP and HIPAA regulations – prior training certifications a plus.
  • Prior experience in managing monitoring visits, study start-up, and close-out activities required.

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CAPA Engineer

Job Category:

CAPA Engineer

Job Location:

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Experience required:

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Responsibilities

  • Independently lead CAPA Investigations, including completing thorough root cause investigations related to medical device design and manufacturing, and Quality System processes.
  • Determine implementation dates and provide documentation to support effectiveness of proposed corrective and preventive actions.
  • Independently facilitate communication with CAPA sponsors and related stakeholders.
  • Document CAPA using CAPA software program(s).
  • Independently interface with cross-functional teams to complete CAPAs in an efficient and effective manner per established CAPA timeliness and effectiveness goals.
  • Generate pertinent documentation relating to the product and manufacturing modifications.
  • Coordinate building and test prototypes of device modifications.
  • Provide training to assembly personnel during the introduction of a product or process modification.
  • Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
  • Must strictly adhere to safety requirements.
  • Maintain regular and punctual attendance.
  • Must maintain company quality and quantity standards.
  • Must have effective oral and written communication skills.
  • Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
  • Ability to remain calm and receptive in fast paced situations.
  • Perform other duties as assigned.
  • 4 year college degree in a technical discipline and 3 years of prior relevant experience. Advanced degrees (Masters or PhD) in an Engineering discipline may reduce the years of experience requirement.
  • Self motivated with the ability to work independently and in a team.
  • Excellent oral and written communication and organizational skills.
  • Knowledge of Excel, PowerPoint, Word, and Visio.
  • Must be able to perform the essential functions of the job, with or without reasonable accommodations.
  • Limited exposure to hazardous chemicals used in the manufacture of the product.
  • Good Manual dexterity.

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CRM Consultant

Job Category:

CRM Consultant

Job Location:

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Experience required:

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Require a strong CRM Consultant with 10+ years of CRM experience & should have been as a Business analyst for at least 2 CRM implementations.

Must have driven Business discussions/workshops and should have worked on CRM functional design covering functionalities like Customer management, Contact Management, Activities, Opportunities, etc.
Must have provided high level solution to Business & driven the solution workshops.

Must have knowledge of co-ordination between among different teams like Development, QA, etc.

Should have given Training to Business Users on functionality being rolled out

Should have worked in the SFA & Field sales execution implementation of CRM.

Should have deep understanding of multiple industry domains.

Must have strong communication skills and be comfortable in leasing with stakeholders independently

Ability to establish priorities, work independently and lead development of different CRM solutions.

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Big Data Analyst

Job Category:

Big Data Analyst

Job Location:

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Experience required:

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Required Skills:
Must be very strong with SQL and have had extensive experience structuring complex SQL queries
Must be strong with Python scripting
Must have data analysis experience
Ideally will have data modeling experience
Ideally will have experience in a big data environment
Bachelor’s degree in a technical field such as computer science, computer engineering or related field required

Bonus/Soft Skills:
MUST have excellent written and verbal communication skills – this is arguably one, if not the most important skills that our client is looking for folks to possess.

High level of intellectual curiosity
Someone who really takes ownership of their work and knows that space like the back of their hand!
Experience with data visualization tools
Data science experience
Financial Industry experience.
Master’s Degree in Technical area
Masters of Business Administration (MBA)

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Security Architect

Job Category:

Security Architect

Job Location:

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Experience required:

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Essential Requirements
• 10+ years of software development experience
• Strong problem-solving and analytical skills
• Agility to adapt to technologies and processes quickly
• Strong development/programming experience in OOP languages like Java/C#
• Knowledge of web technologies like JavaScript, HTTP, and REST
• Experience building and leading general application security improvements in a multi-tenant, cloud based platform
• The ability to effectively communicate software architectures, designs, and security concepts both verbally and in writing

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.Net Developer

Job Category:

.Net Developer

Job Location:

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Experience required:

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As an application developer, you will be responsible for developing, enhancing and maintaining a suite of web-based applications & databases that are critical to operations and the company’s growth. We are looking for an individual with 5+ years software development work experience using any of the following tools: .Net, Vue.js, Node.js, Angular, React, SQL. Elasticsearch experience is a plus. The right candidate must be curious minded, detail oriented, demonstrate good communication skills and committed to success.

Skills and competencies:

  • Must excel at working with peers within a team environment.
  • Vue.js / Node.js JavaScript experience desired
  • SQL Server database development skills desired
  • Ability to meet project plan timelines and produce a high-quality product.
  • Ability to take individual initiative and accountability for assignments.
  • Ability to adapt to changing priorities.
  • Ability to quickly learn and apply new tools and technologies.
  • strong conceptualization, analytical, and logic skills.
  • Detail-oriented with respect to documentation and communication.
  • Effective communicator regarding issues, objectives, initiatives.

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Full-Stack Developer

Job Category:

Full-Stack Developer

Job Location:

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Experience required:

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  • Analyzes and estimates feasibility, time, compatibility with other systems, and computer capabilities.
  • Develops and maintains plans outlining steps and timetables for developing, testing, and installing applications.
  • Researches and evaluates software and hardware to assist in programming or to use as program platforms.
  • Convert designs and specifications into computer code.
  • Designs and codes screen layouts, graphical user interfaces, printed outputs, and interfaces with other systems.
  • Compiles code into programs and corrects errors detected in compile process.
  • Creates test transactions and runs tests to find errors and confirm program meets specifications.
  • Analyzes codes to find causes of errors and revises programs.
  • May consult with client to prototype, refine, test, and debug programs to attain client approval.
  • Writes and maintains documentation to describe program development, logic, coding, testing, changes, and corrections.
  • Writes documentation or reviews documentation written by others that describes installation and operating procedures.
  • Provide technical assistance by responding to inquiries regarding errors, problems, or questions with program.
  • Train end users or technical support staff to use programs.
  • Monitor performance of programs after implementation.
  • Experience level: Experienced
  • Minimum 5 years of experience
  • Education: Bachelors
  • SQL
  • SSRS
  • SSIS
  • ASP.NET
  • WCF
  • Git

  • Angular JS

  • HTML

  • Visual Studio

  • CSS

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Java Developer

Job Category:

Java Developer

Job Location:

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Experience required:

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Job Description:

  • Java Programming language – Analyze, design, build & test changes in an agile environment to Java based application for Claims Processing functional areas.
  • Design & develop software applications that include OO design principles, Test Driven Development, Design Patterns, Security & Performance.
  • Coordinate testing & defect resolutions with test & development teams.
  • Identify root causes & troubleshoot/resolve data, performance, and/or system issues.
  • Work closely with business analysts, application architects, & scrum team to meet standards & requirements for deliverables.
  • 2+ years Java EJB based middleware and backend business processes development.
  • 2+ years’ Service Oriented Architecture and web services expertise.
  • 2+ years Spring Batch with JPA/Hibernate persistence layer experience.
  • 2+ years Edifecs Xengine XES routes and EAM development/configurations.
  • 2+ years Familiarity with application servers like WebLogic/WebSphere and ESBs like Oracle Service Bus.

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UI/UX Designer

Job Category:

UI/UX Designer

Job Location:

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Experience required:

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As a User Experience Designer, you will…

  • Participate as a member of a UX project team; collaborating with UX peers and cross-functional teammates from product, insights & analytics, engineering, customer service, marketing, and QA.
  • Work iteratively to design, refine, and validate solutions. Using your design skills, you create wireframes, storyboards, walkthroughs and prototypes that communicate your design ideas.
  • Build libraries for design tools, contribute and maintain design documentation in Figma, drive alignment across partners, and create detailed design specifications for engineering partners.
  • Work with our design and engineering team to improve design patterns, standards, methods, and/or processes for our team.
  • Partner with User Research to ensure that your design concepts meet our customer’s expectations and will deliver the desired results.
  • Prepare documentation to ensure your designs are well understood by stakeholders and detailed enough for efficient development.
  • Deliver designs that promote our service-wide User Experience Strategy, and utilize our UX Design System, driving coherence and continuity.
  • 6+ years of experience as a user experience designer, product designer, interaction designer, information architect, or similar role.
  • Experience with variety of design tools for an effective approach, estimate, and plan in response to design requests.
  • Experience with several design approaches, methods, and tools that you can use to plan and estimate your project work.

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UI/UX Developer

Job Category:

UI/UX Developer

Job Location:

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Experience required:

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The UI/UX Designer is responsible for the overall consumer-facing digital user experience, including that of websites and various other digital assets, such as delivering high-performing conversion optimized landing pages and digital ad assets. This individual will research and create user journeys, using findings and industry best practices to design aesthetically appealing and functional user experiences. Facilitate the development of user experiences across network of websites and digital products. This position will be a part of a growing Digital Marketing Team and will be a key player in a major website redesign. This is an exciting opportunity to contribute to best-in-class marketing strategies and create digital products that will revolutionize the industry.

Education: Bachelor’s degree in web/interaction design, computer/human interface, information design, computer science, graphic design or related field

  • At least 4 years’ experience in user-centered research and design for responsive, cross-browser and mobile experiences
  • Expereice with JavaScript, React, CSS.
  • Experience administering moderated and unmoderated user testing, in-person and online
  • Experience working in an Agile environment/team a plus.
  • Experience working in Google Analytics a plus.
  • Familiarity with responsive front-end frameworks like Bootstrap a plus.

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Web Developer

Job Category:

Web Developer

Job Location:

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Experience required:

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Job Description

  • Implement new website functionality as assigned. Test and document new code. Research new technologies and evaluate potential impact on website operations. Replace legacy website functions with new modules. Program standalone microsites.
  • Troubleshoot assigned website issues, evaluate possible solutions and implement best option. Enhance existing website areas. Improve workflows, online data gathering and content management. Optimize individual web pages for usability, accessibility, download speed, search engine crawling and social network integration.
  • Provide Tier III level support of website problem resolution support for staff. Coordinates with Help Desk and other IT staff to determine problem resolutions and priorities, also monitors resolution progress and follow-up.
  • Manage work on assigned website development projects. Assist and review work of other IT Staff or third-party developers when implementing changes to the website.
  • Timekeeping, Documenting Procedures, Planning (as assigned), Purchasing (as assigned).

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