Drug-Device Product Development Scientist (On-Site)

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 105,600 - 158,400; Full time

Benefits offered by this job

Annual bonus

Equity awards

Total Rewards benefits

Job summary

Vertex Pharmaceuticals LLC in Boston seeks a Product Development Engineering Scientist to advance combination drug-device products. You will collaborate across R&D, Quality, Regulatory, and Manufacturing to translate requirements into designs and maintain the Design History File.

You will author risk analyses (DFMEA, PFMEA), perform verifications, manage change control, and ensure adherence to cGxP, ISO 13485, and 21 CFR 820.

Qualifications

• Experience with Medical Device Development including ownership and/or authorship of Design History File records and Risk Management deliverables.
• Experience with medical device packaging development and mechanical performance testing is preferred.
• Working knowledge of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
• A strong understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
• A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.

Responsibilities

• Collaborate with cross-functional teams to author the Design History File records and Risk Management deliverables.
• Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
• Translate User Requirements into Design Requirements and support Verification and Validation studies as needed.
• Manage Change Control, Deviations and Non-conformances with Cross-Functional Team for Impact Assessment and Investigations.
• Display attention to detail to ensure complete design history documentation for Process Development and Manufacturing.

Skills

Cross-functional collaboration

Technical writing

Risk management

Statistical analysis

Presentation skills

Education

Engineering degree

PhD with 0-3 years

MS with 3+ years

BS with 6+ years

Job description

Vertex Pharmaceuticals LLC in Boston seeks a Product Development Engineering Scientist to advance combination drug-device products. You will collaborate across R&D, Quality, Regulatory, and Manufacturing to translate requirements into designs and maintain the Design History File.

You will author risk analyses (DFMEA, PFMEA), perform verifications, manage change control, and ensure adherence to cGxP, ISO 13485, and 21 CFR 820.