1. Support the local management to finetune the company localization strategy in R&D function.
2. Work closely with R&D, Regulatory and Product Management function in Ulm to coordinate local 3rd party development in China and implementation of new products into the Chinese market.
3. Collaborate with Product Management, R&D and Regulatory to develop project strategies and translate them into detailed work plans with budgets, resource allocations, milestones, deliverables and project risk management strategies.
4. Implement the localization project plan including but not limited to Lead end-to-end project management for the development, design transfer, localization, and launches of new medical devices and drive improvements for existing ones.
5. Continually update project status (time, budget and resource) to reflect progress against plan and report to senior management.
6. Facilitate seamless cross-functional collaboration, understanding technical, quality assurance, regulatory, and commercial priorities.
7. Collaborate with the 3rd party partner and functional managers, etc. to conduct design verification and validation testing in compliance with regulatory standards
8. Collaborate with the 3rd party partner and functional managers, etc. to maintain documentation on design control and risk management activities for projects
9. Ensure compliance with quality policies, procedures and practices, ensure compliance with all the regulatory and industry standards (FDA, MDD/MDR, ISO, etc.) as appropriate.

1. BS degree or above, concentration in a scientific-related or engineering-related discipline required.
2. 6+ years of project management experience, with at least 3 years in a manufacturing or R&D environment.
3. Proven experience in new product development and launch management, ideally for multinational organizations.
4. Proven experience in design control processes and Class II/III devices and their regulatory clearances.
5. Strong understanding of manufacturing processes, product development cycles, and commercialization workflows.
6. Excellent written and verbal communication skills and proficiency in English.
7. Proven leadership and project management skills, with the ability to work both as a team member and independently.