Principal Mechanical Engineer (Manufacturing Process) - Surgical
Core
Provide technical leadership for the development, characterization, validation, and production readiness of manufacturing and assembly processes for complex precision electromechanical medical products.
Role type
Principal Mechanical Engineer (Manufacturing Process)
Builds
Manufacturing and assembly processes for precision electromechanical surgical devices
Domain
Medical device manufacturing / Precision electromechanics
Required skills
Manufacturing process development, Process validation (IQ/OQ/PQ), DOE, PFMEA, SPC, MSA, Tolerance analysis, GD&T, Root-cause analysis, Process optimization, Equipment/tooling integration
Preferred skills
Precision mechanisms (motors, geartrains, bearings), Medical device experience
Technologies
DOE, PFMEA, SPC, MSA, GD&T
Responsibilities
Own manufacturing and assembly process development from lab to validated production; Lead lab and pilot-line builds and process characterization; Establish process risk and control documentation; Lead process transfer into Manufacturing including validation and ramp-up; Partner with Advanced Manufacturing Engineering on equipment and automation requirements.
Seniority
Principal, hands-on IC with strategic oversight