Product Development Engineering Scientist
Vertex Pharmaceuticals
- Providence, RI
- Permanent
- Full-time
- 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; displays an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes. Prepares definitive specifications or revises – with appropriate testing – as necessary. Aligns with User Requirements, Functional Requirements, and Design Inputs as appropriate. Must be familiar and adhere to C.T.Q. flow down.
- 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.
- Facilitates Design Reviews, ensuring compliance with internal procedures and external standards, and logs minutes and follow-up in Design History File as appropriate.
- Manages Change Control, works with Cross-Functional Team for Impact Assessment, and manages timely completion of activities while ensuring updates are made to relevant documents in Design History File.
- Supports the technical aspects of New Product Commercialization by effectively utilizing product knowledge and first-generation learnings to inform the efficient Design and Development of subsequent product generations.
- Familiarity with Root Cause Analyses relating to Process and Product Development. In addition, with cross-functional input, authors and executes study protocols and applicable testing regimens, and documents all Root Cause Analysis Reports.
- Performs Design History File Remediation as required, including – as applicable – review and revision of all Design and Quality System Documentation.
- M.S with 3+ years, or B.S with 5+ years of experience. Degree in Engineering
- Minimum of 2-5 years of experience working within a regulated medical device environment. Experience with device-biologic combination products
- Proven experience with Medical Device Product Development, ownership and authorship of Design History Files, leading Device Risk Management initiatives, and Lifecycle Management.
- Working knowledge of Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
- A thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
- A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
- Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously.
- Must demonstrate strong interpersonal and teamwork skills.