Product Development Engineering Senior Scientist

Responsibilities

• Collaborate with cross-functional teams to author design history documentation for combination drug-device and biologic device products
• Author comprehensive 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
• Lead Design Reviews to ensure compliance with internal procedures and external regulatory standards
• Manage Change Control, Deviations, and Non-conformances, ensuring timely updates to the Design History File
• Perform Design History File maintenance, including the review and revision of Design and Quality System Documentation

Requirements

• PhD with 2+ years of experience, M.S. with 5+ years, or B.S. with 8+ years of experience
• Proven experience in Medical Device and Combination Product development
• Deep understanding of ISO 13485, ISO 14971, and 21C.F.R.820
• Strong technical writing and presentation skills
• Solid knowledge of statistical principles
• Experience working in highly matrixed environments

Preferred Qualifications

• Degree in Engineering or a related scientific discipline
• Direct experience developing drug delivery systems
• Experience with medical device and drug delivery packaging development
• Knowledge of container closure integrity testing and mechanical performance testing

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 advancing clinical and research programs for life-shortening genetic diseases and other serious conditions through deep insight into human biology.