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Senior Quality Assurance Engineer

Company: Mix-Talent
Location: Marlborough
Posted on: May 16, 2022

Job Description:

Job DescriptionJob DescriptionResponsible for contributing to the design, development and management of projects for new and legacy products, with a focus on Design Assurance activities of medical laser products. Duties:

  • Conduct product design control activities for new and sustaining product development efforts
  • Support risk analysis activities, including design and process FMEA
  • Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
  • Support Design Engineering in the creation of Design History and Technical Files
  • Interact with third-party test houses that conduct compliance testing of our client's products
  • Assist regulatory department with FDA, CE, and other regulatory submissions
  • Perform all other essential duties as assignedRequirements
    • 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices
    • Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred
    • Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek
    • Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
    • Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred
    • Experience with lasers and optical technologies desired, but not necessary
    • Strong working knowledge of Microsoft Word and ExcelEducation Required:
      • Bachelor's Degree in scientific or engineering field; electrical engineering is preferredPersonal Requirements:
        • Excellent oral and written communication, and interpersonal skills
        • Must be able to interact with customers, consultants, and suppliers
        • Ability to work in an environment with competing priorities is necessary
        • Must be able to work in a cross-functional team environment This position must meet Export Control compliance requirements, therefore a US Person as defined by 22C.F.R. 120.15 are required. US Person includes US Citizen, lawful permanent resident, refugee, asylee. License exception Technology and software under restriction (TSR) defined in 15 CFR 740.6 may permit person from Country Group B.

Keywords: Mix-Talent, Boston , Senior Quality Assurance Engineer, Engineering , Marlborough, Massachusetts

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