Sr. Manufacturing Engineer
Core
Lead sustaining manufacturing operations for medical device production, ensuring high-scale output, process optimization, and regulatory compliance.
Role type
Senior Manufacturing Engineer (Individual Contributor)
Builds
Medical device assemblies and systems for cardiovascular, neuroscience, and surgical care
Domain
Medical Device Manufacturing / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control, root cause analysis, process validation (IQ/OQ/PQ), equipment qualification, GD&T interpretation, risk management (pFMEA/dFMEA), regulatory compliance (FDA 21 CFR Part 820, ISO 13485), production document authoring, supplier management, process optimization
Preferred skills
PLM tools (Agile, PTC Windchill), New Product Introduction/Transfer execution, Test Method Validation (TMV), contract manufacturer management
Technologies
PTC Windchill, Agile
Responsibilities
Oversee shift operations to maintain continuous production; investigate and resolve equipment, process, and product non-conformances; design and optimize manufacturing processes, layouts, and workflows; partner with NPI teams to execute calibration and validation protocols; provide training and support to production teams; ensure compliance with regulatory requirements and inspection/test plans.
Seniority
Senior, hands-on IC