Product Development Engineer
About the Job
In June 2019, Vertex announced the establishment of new research sites in Boston and Providence where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy, and Type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (V.C.G.T.), our research teams will bring together the best biology, technologies, and enhanced manufacturing capabilities, to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.
Reporting to the Sr. Manager of Product Development, this role will focus on the design transfer of implantable cell encapsulation devices for delivering proprietary cells. The successful candidate will join the Process Engineering Team and work closely with Research and Development, Device Quality Control, Device Quality Assurance, Regulatory Affairs, and Manufacturing Functions, as required. The position will be located in Providence, R.I..
- 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.
- Familiarity with Risk Analyses, including d.F.M.E.A., u.F.M.E.A., and p.F.M.E.A. Ability 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.
- B.S or M.S in engineering or another relevant discipline.
- Minimum of 3 years of experience working within a medical device environment. Experience with device-biologic combination products is highly desirable.
- 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.
- Comprehensive knowledge of Design Control and Risk Management, including experience using F.M.E.A. analyses, is strongly advantageous.
- 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.