Product Development Engineer
Core
Support commercially released products and drive product/process improvement to ensure compliance, consistency, and robustness in a regulated manufacturing environment.
Role type
Senior Product Development Engineer (Manufacturing/Sustaining)
Builds
Manufacturing processes, product changes, and qualification activities for industrial and life sciences products
Domain
Life Sciences / Industrial Manufacturing / Regulated Environments
Required skills
Technical impact assessment, Change control, Verification & Validation, Engineering documentation, Cross-functional collaboration, Risk analysis
Preferred skills
FMEA, Statistical analysis, Filtration/separation technologies, GMP/ISO standards, Plant operations
Technologies
GMP, ISO 9001, ISO 13485, FMEA, Statistical tools
Responsibilities
Lead material, supplier, and equipment change assessments; Author engineering assessments and change documentation; Execute verification and validation testing; Partner with Manufacturing, Quality, and Regulatory teams; Analyze technical problems to ensure design intent is maintained.
Seniority
Senior, hands-on IC
