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
Senior IC manufacturing engineering manager (contract manufacturing)
Builds
Medical device supply chain continuity, product quality, and manufacturing readiness for ECG and wound care portfolios
Domain
Medical devices / Contract Manufacturing / Supply Chain
Required skills
Contract manufacturer management, supplier performance evaluation, regulatory compliance, process improvement, risk mitigation, cross-functional leadership, project management, on-site audit coordination, strategic supplier relationship management
Preferred skills
Biomedical/Mechatronics/Manufacturing engineering background, ECG product experience, patient monitoring accessories knowledge, 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; Act as expert in managing technical, operational, and logistical aspects of projects from initiation through commercialization; Coordinate process audits, supplier audits, and 3rd party inspections; Analyze and support action required for key performance indicators through balanced scorecard reviews; Manage internal and CM assets related to products; Host regular meetings with CMs to monitor operational activities; Escalate risks and tactical operational issues; 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; Travel approximately 50% of the time visiting critical CMs on-site
Seniority
Senior, hands-on IC with mentorship responsibilities