This is an exciting opportunity to join the Global Supply Chain (GSC) – Irvine Advanced Technology/Transcatheter Mitral Tricuspid Therapies (TMTT) operation integration organization leading the technical integration for TMTT implantable products. The Principal Manufacturing Engineer (Technical Integrator) will served as a main interface between R&D, Pilot and commercial manufacturing, contribute to from Early Human Use to commercialization of new product in the TMTT business unit, and the development of new or optimized manufacturing processes for TMTT in Heart Valve Center operations.
- Serve as the technical integrator supporting the design transfer of TMTT products to Pilot Operations, as well as commercialization activities, by ensuring R&D processes are characterized and scaled up by utilizing new technology and standard work.
- Lead in the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards.
- Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) on a simple product line to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
- Train, coach, and guide lower level employees on more complex procedures.
- Oversee manufacturing support tasks; give instruction to engineers/ technicians on conducting tests; train engineers/ technicians and provide feedback; and coordinate engineer/ technician work.
- Lead and establish complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
- Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
- Perform other duties and responsibilities assigned.
- Bachelor's Degree in in Engineering or Scientific field with 8 years of engineering manufacturing.
- Master’s degree in Engineering preferred.
- Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.
- Understanding of statistical techniques is required. Lean Six Sigma certification is preferred.
- Effective communication and project management skills are required.
- Strong analytical, problem solving, and technical writing skills are preferred.
- Ability to work well independently based on minimal guidance.
- Strong interpersonal and intercultural skills are required.
- Ability to work across various time zones and to travel domestically up to 15%.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.