Product Lifecycle Engineering Principal Scientist - Medical Device & Combination Products
Vertex Pharmaceuticals
June 27, 2026
On-site
Boston, MA
Clinical Research and Development
Key Responsibilities:
- Lead sustaining engineering activities for commercialized medical devices and drug delivery combination products.
- Maintain/update design history documentation, engineering records, and lifecycle deliverables per internal procedures and regulatory expectations.
- Keep risk management documentation current and aligned with post-market changes, investigations, and commercialization needs.
- Support assessments for design changes, component/supplier updates, and product improvements.
- Partner with Quality Assurance, Regulatory Affairs, Process Development, Analytical, Labeling, and Manufacturing to implement lifecycle changes.
- Resolve technical issues from commercialization and post-market support.
- Provide engineering input to change control, deviation investigations, CAPA, and nonconformance activities.
- Ensure continued compliance with design control, risk management, and medical device/combination product requirements.
- Drive data-driven decisions for robustness, reliability, and manufacturability.
- Identify opportunities to improve sustaining engineering processes, documentation, and cross-functional workflows.
- Serve as a technical resource for lifecycle management; author regulatory submission documentation as needed.
Experience/Qualifications:
- Experience developing combination products, specifically drug delivery systems.
- Experience with design controls and risk management for FDA/EU MDR and harmonized standards (ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4) and strong GxP understanding.
- 10+ years in regulated medical device, drug delivery, and combination product environment.
- Bachelor’s degree in Mechanical/Biomedical/Chemical/Materials Engineering or related field.
- Sustaining engineering/product lifecycle/post-market design assurance experience with cross-functional Quality/Regulatory/Manufacturing teams.
- Knowledge of process engineering/manufacturing, analytical methods, labeling/packaging, and systems engineering.
- Strong technical writing, problem-solving, communication; ability to manage multiple priorities in matrixed environments.
Compensation/Benefits (as stated):
- Pay range: $145,600–$218,400; eligible for annual bonus and annual equity awards.
Location/Other:
- On-site in Boston, MA; occasional travel to other locations.
- Lead sustaining engineering activities for commercialized medical devices and drug delivery combination products.
- Maintain/update design history documentation, engineering records, and lifecycle deliverables per internal procedures and regulatory expectations.
- Keep risk management documentation current and aligned with post-market changes, investigations, and commercialization needs.
- Support assessments for design changes, component/supplier updates, and product improvements.
- Partner with Quality Assurance, Regulatory Affairs, Process Development, Analytical, Labeling, and Manufacturing to implement lifecycle changes.
- Resolve technical issues from commercialization and post-market support.
- Provide engineering input to change control, deviation investigations, CAPA, and nonconformance activities.
- Ensure continued compliance with design control, risk management, and medical device/combination product requirements.
- Drive data-driven decisions for robustness, reliability, and manufacturability.
- Identify opportunities to improve sustaining engineering processes, documentation, and cross-functional workflows.
- Serve as a technical resource for lifecycle management; author regulatory submission documentation as needed.
Experience/Qualifications:
- Experience developing combination products, specifically drug delivery systems.
- Experience with design controls and risk management for FDA/EU MDR and harmonized standards (ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4) and strong GxP understanding.
- 10+ years in regulated medical device, drug delivery, and combination product environment.
- Bachelor’s degree in Mechanical/Biomedical/Chemical/Materials Engineering or related field.
- Sustaining engineering/product lifecycle/post-market design assurance experience with cross-functional Quality/Regulatory/Manufacturing teams.
- Knowledge of process engineering/manufacturing, analytical methods, labeling/packaging, and systems engineering.
- Strong technical writing, problem-solving, communication; ability to manage multiple priorities in matrixed environments.
Compensation/Benefits (as stated):
- Pay range: $145,600–$218,400; eligible for annual bonus and annual equity awards.
Location/Other:
- On-site in Boston, MA; occasional travel to other locations.