Product Development Engineering Senior Scientist - Medical Device & Combination Products

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, biologic, 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 diseases Vertex is focused on. At Vertex, our teams bring together the best talent to ensure we bring these cutting‑edge transformative therapies to patients as quickly as possible.

The Product Development Engineering Senior Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering Senior Scientist will work closely with Research and Development, Device Quality Control, Device Quality Assurance, Process Development, Clinical/Commercial Packaging & Labeling Functions, Regulatory Affairs, and Manufacturing Functions, as required.

• Collaborate with highly cross‑functional teams to author the design history documentation of combination drug‑device and/or biologic device products.
• Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
• Translate User Requirements into Design Requirements as appropriate. Correlate Design Inputs with Design Outputs and support Design Verification and Validation Studies (as needed) to be executed both internally and externally.
• Lead Design Reviews to completion, ensuring compliance with internal procedures and external standards.
• Manage Change Control, Deviations and Non‑conformances with Cross‑Functional Team for Impact Assessment and Investigations, and manage timely completion of activities while ensuring updates are made to relevant documents in Design History File.
• Perform Design History File maintenance as required, including - as applicable - review and revision of all Design and Quality System Documentation.
• Display an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes. Align with User Requirements, Functional Requirements, and Design Inputs as appropriate. Must be familiar and adhere to C.T.Q. flow down.

• Proven experience with Medical Device and Combination Product Development including ownership and authorship of Design and Development file records and leading Risk Management initiatives.
• Working knowledge of development and characterization of Test Methods for selection, verification and validation of components, sub‑systems and assemblies.
• Able to present to cross‑functional team for input, alignment, and design and risk file updates.
• Must have experience executing work streams in highly matrixed environments.
• Experience with medical device and drug delivery packaging development, container closure integrity testing and mechanical performance testing.
• A thorough understanding of cGxP 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.

• PhD with 2+ years of experience, M.S. with 5+ years, or B.S. with 8+ years of experience.
• Degree in Engineering preferred but will consider other related disciplines. Experience developing drug delivery systems is strongly preferred.

May require occasional travel to other Vertex locations.

$126,600 - $189,800

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job‑related factors permitted by law.

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