Product Development Engineering Scientist

Responsibilities

• Collaborate with cross-functional teams to author design history documentation for combination drug-device and biologic device products.
• Author critical Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
• Translate User Requirements into Design Requirements and correlate Design Inputs with Design Outputs.
• Support Design Verification and Validation studies through internal and external execution.
• Manage Change Control, Deviations, and Non-conformances, ensuring timely impact assessments and investigations.
• Maintain the Design History File (DHF) through regular review and revision of Design and Quality System documentation.

Requirements

• B.S. or M.S. in engineering or a relevant scientific discipline.
• 2 years of professional experience working within a medical device environment.
• Proven experience with medical device development, including ownership of Design and Development file records.
• Demonstrated experience authoring Risk Management deliverables.
• Strong understanding of ISO 13485, ISO 14971, and 21C.F.R.820.
• Solid understanding of statistical principles.
• Excellent technical writing and presentation skills.

Preferred Qualifications

• Experience with medical device packaging development and mechanical performance testing.
• Working knowledge of test method selection, verification, and validation for components, sub-systems, and assemblies.

Benefits

• Competitive salary with eligibility for annual bonuses and 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 and student loan repayment support.
• 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. Based in Boston, Vertex is dedicated to advancing clinical and research programs for life-shortening genetic diseases and other serious conditions through deep insight into human biology.