Product Lifecycle Engineering Principal Scientist

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 regulatory expectations.
• Ensure risk management documentation is current and aligned with post-market product changes and investigations.
• Support engineering assessments related to design changes, component updates, supplier changes, and product improvements.
• Partner with Quality Assurance, Regulatory Affairs, Process Development, and Manufacturing to implement lifecycle changes effectively.
• Evaluate technical issues arising during commercialization and drive timely resolution.
• Provide engineering input to change control, deviation investigations, CAPA, and nonconformance activities.
• Support Regulatory activities, including authoring regulatory submission documentation.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Chemical, or Materials Engineering, or a related scientific discipline.
• Minimum of 10 years of experience in a regulated medical device, drug delivery, or combination product environment.
• Proven experience with design controls and risk management (ISO 13485, ISO 14971, 21CFR.820, and 21CFR Part 4).
• Demonstrated experience in sustaining engineering, product lifecycle management, or post-market design assurance.
• Experience leading technical teams and projects in highly matrixed environments.
• Strong technical writing, problem-solving, and communication skills.
• Working knowledge of process engineering, manufacturing methods, and systems engineering.

Benefits

• Competitive base salary with eligibility for annual bonuses and annual equity awards.
• Comprehensive medical, dental, and vision benefits.
• Generous paid time off, including a week-long company shutdown in the Summer and Winter.
• Educational assistance programs, including student loan repayment.
• 401(k) with company matching.
• Commuting subsidies.

About the Company

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company is dedicated to treating the underlying causes of multiple chronic, life-shortening genetic diseases and continues to advance a robust clinical pipeline across various therapeutic modalities.