Supplier Development Engineer

Supplier Development Engineer

POSITION SUMMARY:

Supplier Development Engineer is responsible for selection and development of assigned products/suppliers for production, new product development, and non production materials on a company wide basis.

DUTIES & RESPONSIBILITIES:

Reporting to the Supplier Development Manager, key responsibilities of this position include:
Company wide leadership for supplier development coordination with external suppliers: Provide technical expertise and leadership for sourcing and development of supplier's capabilities with respect to technology, performance, quality, cost, logistics, and delivery. Partner with internal groups such as Program Management, Design Engineering and Quality Engineering define requirements and set standards of performance for suppliers. Assist suppliers to ensure that selection, development, and validation of manufacturing processes, equipment, and tooling are performed to the meet state of the art ISO and FDA requirements. Conduct supplier audits, supplier ratings and risk assessments. Monitor and track the progress of supplier's development, internal conformance to standards and readiness evaluations Facilitate and manage qualification testing that leads to the approval of components for use in implantable products. Provide ongoing quality monitoring and interface with external vendors on line issues to ensure highest quality product is maintained. Resolve supplier component-related problems, including yield issues and failure analyses. Evaluate and recommend corrective actions to improve process yields. Lead the effort to develop new process technology to support the manufacturing and ramp of next generation device projects Interface with Design Engineers to provide timely feedback on proposed designs and influence organization to develop strong design for manufacturability culture. Train and educate suppliers on industry best practices and requirements to develop and improve their ability to meet world class expectations. Support management with supplier development strategies and initiatives. Provide input and direction on all initiatives in order to constantly improve the overall effectiveness of Supplier Development Properly document activities in accordance with best engineering practices, company procedures, and regulatory requirements.

POSITION QUALIFICATION REQUIREMENTS:Bachelor of science degree in Materials Science, Electrical, or Mechanical Engineering, and 3 years of experience in medical or other high-reliability manufacturing environment, or equivalent combination of education and experience. Demonstrated analytical, failure analysis and resolution skills Demonstrated strategic planning and critical thinking skills to be able to plan, organize and manage multiple complex priorities. A well developed understanding of manufacturing process validation methodology to meet ISO and FDA requirements. Ability to read and interpret engineering drawings for the purpose of understanding equipment function and product design. Proven strong interpersonal, management and supervision skills Experience with statistical tools like DOE and SPC. Demonstrated negotiating skills. Strong written, presentation and communications skills. Experience with Just in Time and Lean Manufacturing techniques. Excellent computer knowledge and skills. Willingness to travel.

POSITION PREFERENCES:Medical Device manufacturing experience, including ISO and FDA requirements. Equipment knowledge and process experience for SMT, electrical tests, glass to metal seals, spot welding, adhesive bonding, or laser welding. CAD Mechanical design experience developing tooling and fixtures.





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