Senior Quality Engineer, Metals Process Engineering

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Principal Quality Engineer position is a unique career opportunity that could be your next step towards an exciting future.

As a Senior Quality Engineer within the Metals Process Engineering Group (MPEG), you will support nitinol frame and implant component development. This role will support multiple phases of nitinol product(s) development projects such as design verification, validations, launch and stabilize, and transfers to Ireland and Singapore. As the Quality engineer, you will support advanced characterization, functional testing, and inspection development. You will also provide advanced understanding of the product development process, risk management, process monitoring and control, validations, traceability and risk-based decision making.

• Support or lead identification, development, and optimization of complex material characterization, testing methods, and inspection processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for development of nitinol frame and component processes.
• Implement advance process monitoring and statistical process control of complex processes to drive process control, capability and stability.
• Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to validate and improve products (including evaluation of source materials and suppliers) and establish robust manufacturing processes/test methods based on engineering principles; ensure completion of comprehensive process validations (TMV/IQ/OQ/PQ), including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion.
• Collaborate with engineers for equipment selection and validation.
• Provide training and mentorship to enable the seamless knowledge transfer of project and manufacturing processes to receiving sites (Draper, Ireland, Singapore)
• Develop technical content of risk management documentation and partner with DA and R&D engineers to ensure nitinol manufacturing considerations are incorporated into RMW, FMEAs, QCPs, etc.
• Lead in the investigation of complex manufacturing product quality and compliance issues (e.g., Material Review Board, SCAR, CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
• Train, coach, and guide other quality engineers on complex principles
• Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
• Review and approve compliant change control.
• Other incidental duties

• Bachelor’s degree in Engineering or a scientific field with 4 years of relevant experience, or Master’s degree in Engineering or a scientific field with 3 years of relevant experience.

• Experience with manufacturing of metal implants, frames, stents, valves, delivery system components, or other precision implantable devices.
• Experience supporting NPD/NPI programs, along with design verification, design validation, process validation, and product launch activities.
• Supporting design transfer and manufacturing transfers.
• Developing inspection strategies and test methods for implantable products.
• Experience with pFMEA, dFMEA, process characterization, and process controls.
• Experience using risk-based decision making throughout the product lifecycle.
• Leading IQ/OQ/PQ and process validation activities.
• Proven expertise in statistical techniques and SPC
• Experience with automation, software testing, and software validation is strongly preferred
• Proven expertise in usage of MS Office Suite
• Ability to read and interpret…