Principal Engineer, Contract Manufacturing（首席外协制造工程师）
Core
Primary technical leader managing strategic contract manufacturing partners for medical device portfolios including ECG cables, lead wires, electrodes, and wound drain products across the Asia Pacific region.
Role type
Principal Engineer, Contract Manufacturing
Builds
Medical device manufacturing supply chain continuity and product lifecycle excellence
Domain
Medical Devices / Contract Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Contract manufacturer management, supplier performance evaluation, regulatory compliance, process improvement, risk mitigation, cross-functional leadership, project management, on-site inspection coordination, capital asset management, program management for new product launches
Preferred skills
Biomedical/Mechatronics/Manufacturing engineering background, ECG product knowledge, patient monitoring accessories expertise, wound care product experience, Lean Six Sigma, PMP
Technologies
None explicitly stated
Responsibilities
Serve as primary technical point of contact for assigned contract manufacturers in China and Asia Pacific; Manage metrics targets with CMs regarding service, delivery, quality, compliance, and cost; Establish robust tracking and reporting processes for regulatory commitments; Coordinate process audits, supplier audits, and third-party inspections; Lead problem solving on production assurance, scheduling, and replanning; Lead CM capability building and product changes/introduction/exit; Take on program manager role for new product launch and supplier onboarding; Host regular meetings with CMs to monitor operational activities; Escalate risks and tactical operational issues; Manage internal and CM assets related to products including capital requests and traceability
Seniority
Principal, strategic leadership with hands-on technical execution
