Principal Engineer - Molding
Core
Provide technical leadership for verification and validation of medical devices, molded components, and manufacturing processes to ensure regulatory compliance and product performance.
Role type
Principal Engineer (Medical Device Manufacturing & Validation)
Builds
Medical devices, molded components, and validated manufacturing processes
Domain
Medical Devices / Polymer Engineering / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Verification and validation (V&V) protocols, root cause analysis, risk assessment, process improvement, design controls, regulatory standards knowledge (ASTM, ISO, EN), polymer and material characteristics, test method development, mentorship
Preferred skills
Design of Experiments (DOE), advanced statistical software (Minitab), 510k process, Class II medical device launch experience, CAPA management, equipment qualification
Technologies
Minitab, ASTM, ISO, EN
Responsibilities
Develop and execute V&V protocols for complex molded products; Analyze test results and lead failure investigations; Lead process improvement and CAPA activities; Mentor junior engineers and lead small project teams; Coordinate cross-functional teams across product development and manufacturing; Document testing procedures and compliance trails
Seniority
Principal, hands-on IC with strategic influence
