Product Development Engineering Scientist
Core
Develop combination drug-device and biologic device products, focusing on drug delivery systems and mechanical performance testing.
Role type
Product Development Engineering Scientist
Builds
Combination drug-device and biologic device products
Domain
Biotechnology / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical device development, Design History File authorship, Risk Management (DFMEA, UFMEA, PFMEA), cGxP principles, ISO 13485, ISO 14971, 21C.F.R.820, statistical principles, technical writing
Preferred skills
Medical device packaging development, mechanical performance testing, component verification and validation
Technologies
None stated
Responsibilities
Author design history documentation for combination products, perform risk analyses and biocompatibility assessments, translate user requirements into design requirements, manage change control and deviations, maintain Design History File
Seniority
Mid-level, hands-on IC
