Product Lifecycle Engineering Principal Scientist - Medical Device & Combination Products

Vertex Inc.•Boston, MA

1d•Onsite

About The Position

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.

Requirements

Must have experience with product development of combination products, specifically drug delivery systems.
Must have experience with design controls and risk management as it pertains to FDA, EU MDR, and associated harmonized standards (ISO 13485, ISO 14971, 21CFR.820 and 21CFR Part 4) and a thorough understanding of GxP principles and practices.
Must have experience leading technical teams and projects in highly matrixed environments.
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Engineering, or related scientific/engineering discipline.
Minimum of 10 years of experience working within a regulated medical device, drug delivery, and combination product environment.
Strong knowledge of design controls and risk management for regulated products.
Demonstrated experience in sustaining engineering, product lifecycle management, or post-market design assurance in collaboration with cross-functional product support from Quality, Regulatory, and Manufacturing teams.
Working knowledge of process engineering and manufacturing methods, analytical methods, labeling and packaging, and systems engineering.
Strong technical writing, problem-solving, and communication skills.
Ability to manage multiple priorities and work effectively across teams.
Experience supporting change assessments and design updates in a structured quality system.

Responsibilities

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.
Support continued compliance with applicable design control, risk management, and medical device / combination product requirements.
Contribute to product robustness, reliability, and manufacturability through data-driven engineering decisions.
Participate in cross-functional reviews to ensure product lifecycle activities are appropriately documented and executed.
Identify opportunities for continuous improvement in sustaining engineering processes, documentation practices, and cross-functional workflows.
Serve as a technical resource for lifecycle management activities associated with commercial drug delivery systems.
Support Regulatory activities including authoring regulatory submission documentation.