Job Description - Medical Device Quality Engineer II - Design Assurance in Princeton
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Medical Device Quality Engineer II - Design Assurance

Ref: US_EN_6_971649_1343961

Posted on 09 September 2020
Job Location
Princeton, New Jersey
Contract Type
Contractor
Category
Engineering
Salary
$60 - $70 / Hour

A Medical Device Quality Engineer II – Design Assurance job in Mansfield, MA or Plainsboro, NJ is available through Modis Engineering. You will be responsible for Neuro projects of varying scope and complexity of Class I, Class II and Class III medical devices.  You will interact with internal/external design and development partners, participate on cross-functional project team through all phases of the EU MDR process, and assist technical teams with planning, executing, documenting and communicating all related EU MDR Design Assurance activities. This is a 12-16 month contract opportunity. The salary range is between $60.00 and $70.00 per hour.

Medical Device Quality Engineer II – Design Assurance  job responsibilities include:

  • Lead and/or support EU MDR DHF updates and remediations
  • •             Support external partners in the remediation of Design History Files

    •             Provide statistical oversight to all EU MDR qualification protocols

    •             Provide expertise in Risk Management, Design Verification, Statistical Methods and Design Controls

    •             Coordinate, review and approve development documentation created by internal/external partners, including product requirements, verification and validation test strategy, protocols and reports.

    •             Support Design Reviews, Technical Reviews, and Peer Reviews

    •             Fulfill EU MDR (design control requirements); examples: detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures and EU MDR guidelines

    •             Collaborate with internal and external partners to fulfill company EU MDR objectives

    •             Lead and support EU MDR work streams

    •             Communicate project status to Design Assurance Leadership using EVM or other reporting techniques, identify, report and identify EU MDR program risks and mitigations

    QUALIFICATIONS:

    •             A Bachelor’s degree in Engineering with a minimum of three to five years’ experience in medical device and/or technology development.

    •             Demonstrated knowledge and working practical knowledge of medical device product development including Design Verification & Validation, Risk Management and Statistical Methods, RoHS and REACH Directives

    •             Knowledge of IEC 62366, QSR: FDA 21 CFR 820 and ISO 13485/ 14971/ 10017/ 10993 requirements and knowledge of international Standards: ISO 9000, 

    •             Demonstrates knowledge of and applies statistical analysis to support data-driven decision making. Strong analytical skills

    •             Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary. FDA QSR Design Controls, specifically design verification, design validation and engineering change management.

    •             Lead and coordinate, review and approval of DHF documentation created by internal and external partners, including product requirements, schematics, code, verification and validation test strategy, protocols and reports.

    •             Demonstrates excellent verbal and written communication skills

    •             Proficient with the MS Office Suite, and statistical software.

    •             Must be able to work independently with minimal supervision.

    •             Working knowledge of EU MDR Requirements and Regulations for medical devices

    If you are interested in this Medical Device Quality Engineer II – Design Assurance  job in Mansfield, MA or Plainsboro, NJ then please click APPLY NOW

    Equal Opportunity Employer/Veterans/Disabled

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/

    The Company will consider qualified applicants with arrest and conviction records.

    Equal Opportunity Employer/Veterans/Disabled

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please

    The Company will consider qualified applicants with arrest and conviction records

    Apply

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