As a Sr. Manufacturing Engineer, the individual participates in product development phases as manufacturing engineering lead or liaison. The position will be responsible to assess and provide design for manufacturing (DFM) input to the product design team, and responsible to design and deploy manufacturing fixture and tooling, develop manufacturing processes, establish manufacturing procedures, and lead process validation and design transfer to manufacturing internally or externally.
Core Job Responsibilities:
- Provide product and process DFM (Design for Manufacturing) input to product development core team to enhance manufacturability and reduce product cost.
- Design, document, assemble, qualify and release manufacturing and testing tooling, fixtures equipment. Create and release associated maintenance and calibration procedures.
- Develop and set up manufacturing assembly line, release and/or refine BOMs, work flow processes and detailed MPI work instructions.
- Create required documentation to support the development of products and manufacturing processes. Lead process validation activities, including timelines, responsibilities, and validation protocols/reports.
- Leads or participates in pilot production or production phase and provides inputs to drive new product introduction schedules, resolve manufacturability issues, and drive improvements for cost and efficiency.
- Provide training or assist in training of production staffs for assembly, testing, and the use of new released equipment, methods and procedures.
- Support manufacturing team in maintaining compliance with medical device quality system requirements, including corrective/preventive action closure, disposition of non-conforming materials, and etc.
- Perform process capability analysis, failure analysis for discrepant production components, assemblies or field returns, and troubleshoot manufacturing line issues.
- Other manufacturing engineering duties or support as assigned or requested.
Required Knowledge/Skills, Education, And Experience
- BS degree in Mechanical, Chemical, Biomedical, Materials Engineering or equivalent experience is required.
- 5+ years experience as design or manufacturing engineer supporting product development or production lines. MS degree with 3+ year experience is also considered.
- Strong technical skill in prototyping, tooling development and troubleshooting. Hands-on proficiency with machine shop tools and 3D printers.
- Strong knowledge in materials, BOM structure, and best practices for rigid instrument assembly
- Agile PLM experience is preferred
- Experience with process validation planning/execution, IQ/OQ/PQ protocols and reports.
- Ability to manage multiple priorities in fast-paced environment.
- Prior experience in medical device or other highly regulated industry is preferred.
- Excellent Project Management skills. Experience in Agile product development is a plus.
- Excellent knowledge of 21 CFR part 820 and ISO 13485
- Ability to read and interpret detailed mechanical drawings and communicate technical information. CAD experience with 3D modeling tools is a plus