The opportunity will reside in the Transcatheter Mitral and Tricuspid Therapies (TMTT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews and manage design transfers to manufacturing..
Essential job functions include:
- Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
- Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
- Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and Edwards receiving inspection fixture design for Test method validation.
- Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
- Ensure that Tier 1 suppliers are using capable Tier 2 suppliers for material and outside processing services.
- Supports IQ/OQ/PQ efforts within Edwards and at suppliers. Ensuring proper documentation is completed to meet quality systems requirements. (e.g., Design Reviews, Component Drawings, FMEA’s, Manufacturing Procedures, BOM’s, Routers, etc.).
- Ability to travel approximately 20%: domestic and international.
- Coordinates tooling / process capability studies as required.
- Perform other duties and responsibilities as assigned.
- Bachelor's Degree in Engineering or Scientific field with minimum 6 years of engineering.
- Experience in injection molding, catheter design and manufacturability with a variety of materials including plastics and alloys.
- In-depth knowledge of Design Control requirements and experience generating documentation including Part Qualification Plan, Design Requirements, Risk Management, Design Verification and Validation.
- Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
- On-site work required.
- Master’s degree in Mechanical or Biomedical is preferred.
- Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
- Understanding of statistical techniques.
- CAD experience using ProE preferred.
- Effective communication skills are
- Ability to work well both independently and as a member of a team is essential.
- Strong analytical, problem solving, and technical writing skills are required.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.