Product Development Engineering Senior Scientist - Medical Device & Combination Products
Vertex Pharmaceuticals
June 27, 2026
On-site
Boston, MA
Clinical Research and Development
Product Development Engineering Senior Scientist (Combination Product Development—Drug Delivery Systems)
Key Duties And Responsibilities
- Collaborate with cross-functional teams to author design history documentation for 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; correlate Design Inputs with Design Outputs; support Design Verification and Validation studies (internal/external as needed).
- Lead Design Reviews to completion, ensuring compliance with internal procedures and external standards.
- Manage change control, deviations, and non-conformances for impact assessment and investigations; ensure timely completion and updates to the Design History File.
- Maintain the Design History File, including review/revision of applicable Design and Quality System documentation.
- Ensure completeness and alignment with User Requirements, Functional Requirements, Design Inputs; adhere to C.T.Q. flow down.
Knowledge And Skills (Qualifications)
- Proven experience in medical device and combination product development; ownership/authorship of design and development file records; leading risk management initiatives.
- Working knowledge of development/characterization of test methods for component/sub-system/assembly selection, verification, and validation.
- Ability to present to cross-functional teams and update design and risk files.
- Experience executing workstreams in highly matrixed environments.
- Experience with medical device/drug delivery packaging development, container closure integrity testing, and mechanical performance testing.
- Strong understanding of cGxP; ISO 13485, ISO 14971, and 21 CFR 820.
- Strong statistical principles; technical writing and presentation skills.
- Work independently, multi-task, and support multiple projects; strong interpersonal/teamwork skills.
Education And Experience
- PhD (2+ years) or MS (5+ years) or BS (8+ years). Engineering degree preferred; other related disciplines considered.
- Experience developing drug delivery systems strongly preferred.
May require occasional travel to other locations.
Key Duties And Responsibilities
- Collaborate with cross-functional teams to author design history documentation for 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; correlate Design Inputs with Design Outputs; support Design Verification and Validation studies (internal/external as needed).
- Lead Design Reviews to completion, ensuring compliance with internal procedures and external standards.
- Manage change control, deviations, and non-conformances for impact assessment and investigations; ensure timely completion and updates to the Design History File.
- Maintain the Design History File, including review/revision of applicable Design and Quality System documentation.
- Ensure completeness and alignment with User Requirements, Functional Requirements, Design Inputs; adhere to C.T.Q. flow down.
Knowledge And Skills (Qualifications)
- Proven experience in medical device and combination product development; ownership/authorship of design and development file records; leading risk management initiatives.
- Working knowledge of development/characterization of test methods for component/sub-system/assembly selection, verification, and validation.
- Ability to present to cross-functional teams and update design and risk files.
- Experience executing workstreams in highly matrixed environments.
- Experience with medical device/drug delivery packaging development, container closure integrity testing, and mechanical performance testing.
- Strong understanding of cGxP; ISO 13485, ISO 14971, and 21 CFR 820.
- Strong statistical principles; technical writing and presentation skills.
- Work independently, multi-task, and support multiple projects; strong interpersonal/teamwork skills.
Education And Experience
- PhD (2+ years) or MS (5+ years) or BS (8+ years). Engineering degree preferred; other related disciplines considered.
- Experience developing drug delivery systems strongly preferred.
May require occasional travel to other locations.