Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201049
Primary Function of Position:
- Contributes to the successful support and advancement of high-volume manufacturing for stapler products.
- This position will focus on meeting manufacturing operations and product safety, reliability, and performance goals.
- Individuals in this role must demonstrate excellent knowledge of lean manufacturing, process development and the ability to work with a team to develop state of the art manufacturing lines.
Roles and Responsibilities:
Specific responsibilities for this Manufacturing Engineer position include:
- Provide technical support and failure analysis, for discrepant production components and assemblies.
- Develop, maintain, and improve manufacturing processes using pFMEA as a guide.
- Provide leadership and mentorship to team members as needed.
- Design, build, document and/or specify manufacturing assembly fixtures.
- Establish and perform IQ/OQ/PQ on equipment and fixtures. As well as execute validations on Manufacturing lines (PPQ).
- Support Design Verification and Validation (V&V) activities.
- Contribute to iterative component designs for reliability improvements and cost reductions.
- Assist supplier quality engineers with material procurement issues.
- Support quality system compliance including, discrepant material dispositions, ECO implementation, and nonconforming evaluations.
- BS in engineering (ME or IE disciplines) required, MS preferred.
- Minimum 8 years’ experience in product development or manufacturing environments.
- High mechanical aptitude with a strong background in statistics is a must.
- Experience in mid/high volume manufacturing of complex mechanisms (automation and vision system experience a plus).
- Experience with creating Manufacturing Process Instructions, Procedure writing, and BOM development.
- Ability to lead cross functional teams and give clear and concise presentations.
- CAD experience preferred (Soidworks).
- Use of Agile or similar lifecycle management system tool.
- Experienced in ISO 13485 medical device manufacturing environment.
- Sterilized medical device experience a plus.