Product Engineer
Core
Designing and managing the lifecycle of custom single-use systems (SUT) for biotech customers, from new product introduction to manufacturing support.
Role type
Product Engineer (Mechanical/Industrial Design)
Builds
Custom single-use systems for biotechnology research, vaccines, and cell/gene therapies
Domain
Biotechnology / Life Sciences / Medical Devices
Deliverable
product features
Required skills
Mechanical engineering, Product design, Integrated product development, Industrial design, Manufacturing processes, CAD software (Autodesk Inventor/Solidworks), Product Data Management (Autodesk Vault/EPDM), Process validation (IQ/OQ/PQ), FMEA, Process capability studies
Preferred skills
None stated
Technologies
Autodesk Inventor, Solidworks, Autodesk Vault, EPDM, SAP
Responsibilities
Liaise with sales to review and release customer-specific system drawings; Apply design guidelines to assess manufacturability of new systems; Collaborate with manufacturing to improve production documentation accuracy; Prepare validation protocols and reports for IQ, OQ, and PQ; Manage product changes across the current portfolio
Seniority
Mid-Senior (5+ years experience)
