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- Identify and support the qualificat i on of suppl i ers for materials needed for products.
- Provide manufacturing engineering expertise in the daily operation and maintenance of the assigned manufacturing processes and related business continuity needs in production and to contract manufacturer as needed.
- Provide engineering expertise to the design, fabrication , development, installation , validation and qualification of equipment /fixtures per Quality system requirements.
- Work with Quality Engineering and Production personnel in the conduct of root cause analyses of material and process non-conformances (NCMRs) and implementation of correcti v e actions (CAPAs).
- Work with R&D and Production personnel to manufacture product for Design Verification and to transfer new products and processes into manufacturing environment in-house or to an external contract manufacturer.
- Support engineering testing and documentation that complies with regulatory requirements for regulatory approval or clearance by FDA or other international regulatory bodi e s, as required.
- Working knowledge of Statistical Process Control (SPC), Six Sigma principals and tools and decis io n-making tools Use CAD software such as Auto cad, Solid works Ability to travel to contract manufacturer, attend training activities, and visit suppliers, etc.
- The salary offered will depend on internal pay equity and the candidate's relevant skills, experience, qualifications, and job market data.
Manufacturing Engineer - Fremont, United States - Qapel Medical Inc
