JVT Advisors

Product Development Engineer

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Location: Providence , Rhode Island 02905
Employment Type: Contract

Job Description

Contract Length:  1 year

Responsibilities:

  • Supports compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards. With cross-functional input, drafts Design Control and Risk Management documentation.
  • Builds Design Inputs by collecting User Requirements and translating into Functional Requirements as appropriate. Correlates Design Inputs with Design Outputs and manages Design Verification and Validation Studies.
  • Supports translation of R&D specifications into Design Documentation through experimental design, data analysis and protocol/report writing. Prepares definitive specifications or revises – with appropriate testing – as necessary to be leveraged by Process Development and Manufacturing. Aligns User Requirements, Functional Requirements, and Design Onputs as appropriate.
  • Familiar with Risk Analyses, including d.F.M.E.A., u.F.M.E.A., and p.F.M.E.A. Able to present to Cross-Functional Team for input, revision, and closure. Must be familiar with U.S. F.D.A. and E.U. Risk Analysis methods and, also, those of other regulatory jurisdictions.

Requirements:

  • B.S or M.S in engineering (Biomedical or Mechanical) or another relevant discipline.
  • Minimum of 1-3 years of experience working within a medical device environment. Experience with device-biologic combination products is highly desirable.
  • Experience with Design Control and Risk Management, including experience using F.M.E.A. analyses, is strongly advantageous.
  • Working knowledge of Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
  • Familiarity with c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.

 

Trevor Hoffman

Technical Recruiter

Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.

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