Sr Advanced Manufacturing Engineer
2 weeks ago
Responsibilities :
- Lead projects and oversee deliverables related to Design Transfer and Manufacturing Transfer.
- Collaborate with product development teams to enhance manufacturability and scalability.
- Conduct risk assessments and implement mitigation strategies.
- Create manufacturing documentation and process maps.
- Work with Quality team to define specifications and control plans.
- Execute engineering studies and process validation.
- Develop BOM Structures, Routers, and Engineering Change.
- Optimize manufacturing workflows using Lean principles.
- Oversee production ramp-up and transition plan.
- Manage product lifecycle and sustaining engineering.
- Collaborate with cross-functional teams for seamless integration.
- Experience in statistics and inspection methodologies.
Requirements :
- Bachelor degree in Engineering or equivalent experience.
- Minimum 5 years' experience in regulated manufacturing industry.
- Familiar with NMPA requirements, ISO13485, and medical device standards.
- Knowledge of manufacturing/assembly processes for medical devices.
- Project Management skills (desirable).
- Desirable knowledge in Lean Manufacturing, Validations, Protocol Creation, Solid Works, ERP.
- Understanding of Good Manufacturing Practices, 5s, and Lean Manufacturing.
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