Product Development EngineerApply Now
Location: Providence , Rhode Island 02905
Employment Type: Contract
Contract Length: 1 year
- 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.
- 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 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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