Product Development Engineering Scientist
Vertex Pharmaceuticals
August 15, 2026
On-site
Boston, MA
Operations
General Summary:
The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems.
Key Duties And Responsibilities:
- Collaborate with cross-functional teams to author 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; correlate Design Inputs with Design Outputs; support Design Verification and Validation Studies (internally and externally).
- Manage Change Control, Deviations and Non-conformances with cross-functional teams for impact assessment and investigations; ensure timely completion and updates to the Design History File.
- Perform Design History File maintenance, including review/revision of Design and Quality System Documentation.
- Ensure completeness and alignment with User Requirements, Functional Requirements, and Design Inputs.
Knowledge And Skills:
- Proven experience with Medical Device Development, including ownership/authorship of design and development file records and risk management deliverables.
- Experience with medical device packaging development and mechanical performance testing (preferred).
- Working knowledge of test methods for selecting, verifying, and validating components/sub-systems/assemblies.
- Ability to present to cross-functional teams for input and design/risk file updates.
- Experience executing workstreams in highly matrixed environments.
- Strong understanding of cGxP principles and practices; ISO 13485, ISO 14971, and 21C.F.R.820.
- Strong statistical principles; strong technical writing and presentation skills.
Education And Experience:
- Degree in Engineering preferred (other related disciplines considered).
- PhD (0–3 years), M.S. (3+ years), or B.S. (6+ years).
Pay Range:
- $105,600 - $158,400
The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems.
Key Duties And Responsibilities:
- Collaborate with cross-functional teams to author 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; correlate Design Inputs with Design Outputs; support Design Verification and Validation Studies (internally and externally).
- Manage Change Control, Deviations and Non-conformances with cross-functional teams for impact assessment and investigations; ensure timely completion and updates to the Design History File.
- Perform Design History File maintenance, including review/revision of Design and Quality System Documentation.
- Ensure completeness and alignment with User Requirements, Functional Requirements, and Design Inputs.
Knowledge And Skills:
- Proven experience with Medical Device Development, including ownership/authorship of design and development file records and risk management deliverables.
- Experience with medical device packaging development and mechanical performance testing (preferred).
- Working knowledge of test methods for selecting, verifying, and validating components/sub-systems/assemblies.
- Ability to present to cross-functional teams for input and design/risk file updates.
- Experience executing workstreams in highly matrixed environments.
- Strong understanding of cGxP principles and practices; ISO 13485, ISO 14971, and 21C.F.R.820.
- Strong statistical principles; strong technical writing and presentation skills.
Education And Experience:
- Degree in Engineering preferred (other related disciplines considered).
- PhD (0–3 years), M.S. (3+ years), or B.S. (6+ years).
Pay Range:
- $105,600 - $158,400