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Job Description

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 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..

Key Responsibilities

• Collaborate with highly cross-functional team to manage design controls and risk management activities for novel stem cell-based T1D combination product.
• Lead medical device and combination product packaging development activities, including design, distribution testing, and shelf-life testing.
• Support compilation and maintenance of Design History File(s), ensuring compliance with all internal and external processes, procedures, and standards.
• Support setting of design specifications, including design inputs, user requirements, functional requirements, and design outputs.
• Support Design Verification and Validation activities and studies.
• Support Human Factors Engineering program and has experience interfacing with surgeons and hospital staff to obtain Voice of Customer
• Support regulatory submission documentation
• Familiar with Risk Analyses, including DFMEA, UFMEA, and PFMEA. 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.

Experience:

• Must have experience with product development in medical devices, combination products, or cell and gene therapy products
• Must have experience with Design Controls and/or Risk Management as it pertains to ISO 13485.
• Experience with medical device packaging development, including container closure integrity testing, sterile barrier testing, and cold chain distribution a plus.
• Experience supporting IND and BLA regulatory submissions a plus.
• Familiarity with Type 1 Diabetes (T1D) disease state and/or T1D therapies a plus.

Required Qualifications:

• B.S or M.S in engineering or another relevant discipline.
• Minimum of 3-5 years of experience working within a regulated 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 FMEA 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.

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