Sr Assembly Engineer组装工程师（医疗）
Core
Lead assembly line operations for new product introductions and mass production in the medical device sector, focusing on process validation, efficiency improvement, and quality compliance.
Role type
Senior Assembly Engineer (Medical Devices)
Builds
Medical device products
Domain
Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
New product introduction (NPI), process flow definition, fixture and tooling management, capacity planning, standard time measurement, line balancing, quality issue resolution, regulatory compliance (ISO 13485, FDA 21CFR, EU MDR), post-process manufacturing techniques (ultrasonic welding, dispensing, laser welding, sealing, leak testing, visual inspection)
Preferred skills
None stated
Technologies
Ultrasonic welding, dispensing, laser welding, sealing, leak testing, visual inspection
Responsibilities
Define assembly process flows and validate process parameters; track product trial assembly and resolve issues; measure standard times and optimize line balance; conduct production line audits and enforce work instructions; analyze customer complaints and implement containment/prevention measures; prepare production reports and compliance documentation.
Seniority
Senior, hands-on IC