Principal Mechanical Engineer
仕事内容
Lead the mechanical design of implantable devices (IPGs, leads, surgical tools) from concept through production.
Define product requirements, reliability targets, and design for manufacturability and assembly (DFX).
Develop and validate hermetic sealing, laser welding, overmolding, and adhesive bonding with suppliers and internal teams.
Conduct verification testing, root cause analysis, FMEA, and risk assessments to ensure safety and regulatory compliance.
Create and maintain design control documentation (DHF, ECOs, BOMs, LHRs) and collaborate across disciplines.
Partner with clinicians and cross-functional teams to gather feedback; travel ~10% as needed.
Define product requirements, reliability targets, and design for manufacturability and assembly (DFX).
Develop and validate hermetic sealing, laser welding, overmolding, and adhesive bonding with suppliers and internal teams.
Conduct verification testing, root cause analysis, FMEA, and risk assessments to ensure safety and regulatory compliance.
Create and maintain design control documentation (DHF, ECOs, BOMs, LHRs) and collaborate across disciplines.
Partner with clinicians and cross-functional teams to gather feedback; travel ~10% as needed.
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