Product Development Engineering 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
• 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 experience working within a medical device environment
• Strong knowledge of ISO 13485, ISO 14971, and 21C.F.R.820
• Proven experience with DFMEA, UFMEA, and PFMEA
• Strong statistical principles and technical writing skills
• Experience executing workstreams in highly matrixed environments

Preferred Qualifications

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

Benefits

• 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
• Annual bonus and annual equity awards

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 causal human biology.