Lead Manufacturing Engineer
On-siteSuzhou, Jiangsu, China
Job Summary
Provide advanced technical and engineering support for manufacturing areas and projects, ensuring process and product quality meets OS, material specifications, and GMPs. Lead PFMEA, control plans, SOPs, and PPAP generation for product transfers and scale-ups while conducting process validation, gauge R&R studies, and statistical tool development. Support capital acquisition activities including equipment specification, contract negotiation, and installation validation. Collaborate with Materials Science, Design, and Quality Assurance to troubleshoot systems and drive cross-functional process improvements. Manage non-conformities and CAPAs with QA, mentor engineering technicians, and lead technical initiatives under the Continuous Improvement Program.
Required Qualifications
- English reading and writing is a must
- oral communication should be possible
- Has very good oral and written communication skills
- Has very good presentation skills
- Professional in technical writing
- Professional in problem solving skills
- Professional project management skills
- Strong communication and influencing skills with both internal and external agents
- Capable of technical leading, influencing and providing technical direction to Engineers, Coop Students, Technicians and operators as required
- Confident and effective decision maker
- proven leadership ability to negotiate and influence others
- 10+ years related experience
- Experience in CNC or other manufacturing processes
- Experience in developing and working with small group problem solving teams
- Experience on process development
- Experience on process quality
- B.S or master in Engineering
- ISO 13485/Quality Systems Expertise and Application
- GMP/Medical Device Industry Expertise
- Lean/SPC
- Travel Percentage: 10%
- Onsite
Desired Qualifications
- Experience in medical device industry is preferred
- Experience in developing and working with small group problem solving teams
- Experience on process development
- Experience on process quality
- B.S or master in Engineering preferred
- ISO 13485/Quality Systems Expertise and Application
- GMP/Medical Device Industry Expertise is preferred
- Lean/SPC is preferred
- 10+ years related experience is a plus
- Strong technical background
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