- Lead and establish projects for: production improvements, quality improvements, cost reduction and manufacturing capacity.
- Create and manage department budget including: project headcount analysis, materials, equipment, etc.
- Manage and mentor engineering team and create career development plans and performance goals for team members
- Work with cross function teams to establish project plans and schedule to support product transfer and process improvement to ensure the most efficient path to product commercialization
- Strengthen process development /improvement skills for engineering team by providing training, coaching and mentoring.
- Lead project management, project risk mitigation, budget performance, and provide department/project recommendations to increase team performance
- Interface with the R&D center to leverage technical expertise to expedite product development efforts.
- Maintain compliance with company policies and procedures
- Update senior management on: project status, budget performance, team capability, and recommend opportunities for improvement
- Apply problem solving techniques to resolve product performance and manufacturing issues
- Oversee manufacturing transfer project from R&D into production
- Extensive knowledge on process validation, process change and implementing changes to production level products.
- Minimum 7 years medical device R&D and Operations experience with focus on neurovascular products
- Must have demonstrated skills in leading people and projects
- Demonstrated fact-based reasoning, root cause analysis and problem-solving skills
- Excelled verbal and written communication skills (English and Chinese)
- Full comprehension of ISO/FDA/NMPA requirements
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