Product Lifecycle Engineering Principal Scientist - Medical Device & Combination Products
Listed on 2026-05-30
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Engineering
Biomedical Engineer, Medical Device Industry
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.
As the Product Lifecycle Engineering Principal Scientist, you will focus on the sustaining activity with drug delivery devices and combination products. You will ensure design and development processes and risk documentation associated with drug delivery systems are maintained throughout commercialization post‑market lifecycle. The successful candidate will work closely with Process Development, Quality Assurance, Regulatory Affairs, Analytical, and Manufacturing functions, as required.
The position will be on‑site in Boston, MA.
Collaborate with highly cross‑functional teams to Lead sustaining engineering activities for commercialized medical devices and drug delivery combination products.
Maintain and update design history documentation, engineering records, and lifecycle deliverables in accordance with internal procedures and regulatory expectations.
Ensure risk management documentation is current and aligned with post‑market product changes, investigations, and ongoing commercialization needs.
Support engineering assessments related to design changes, component updates, supplier changes, and product improvements.
Partner with Quality Assurance, Regulatory Affairs, Process Development, Analytical, Labeling, and Manufacturing to assess product impact and implement lifecycle changes effectively.
Evaluate technical issues arising during commercialization and post‑market support, and drive timely resolution.
Provide engineering input to change control, deviation investigations, CAPA, and nonconformance activities, as applicable.
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