Principal Engineer, NPD-Quality

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. Do you thrive on solving difficult problems and turning innovative ideas into life-changing therapies? Our New Product Development Quality team works at the intersection of innovation, risk management, and patient impact. Partnering with engineers, clinicians, and cross-functional teams, you'll help shape the development of breakthrough medical technologies by solving complex challenges, reducing risk, and influencing critical decisions throughout the product development process. In this role, you'll apply quality engineering expertise to enable innovation while ensuring compliance with regulatory requirements and Edwards' quality systems. Every project presents new opportunities to tackle technical challenges, collaborate with diverse teams, and help bring safe, effective, and reliable therapies to patients around the world. How you will make an impact: • Provide leadership and oversight for a device, system, or project to develop, update, and maintain design control documentation through product development processes. Support development of design requirement documentation. • Develop, update, and maintain technical content of risk management and usability files • Lead identification, development, and optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma and Lean manufacturing tools) for design for manufacturing and continuous process improvement initiatives. Identify opportunities and implement solutions for re-design/design of complex equipment, new technologies (including automation and software), tools, fixtures, etc. to improve manufacturing processes and/or test methods, and reduce overall process/product risk profile. • Drive the development and manage the execution of complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and establish robust processes and/or test methods based on engineering principles; ensure completion of comprehensive usability studies, design verification and validation, validations for process and test methods, including analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion • Lead in the investigation of complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development and based on engineering principles; analyze results, make recommendations and develop reports. Act as subject matter expert for internal and/or external audits for products and/or processes. Support regulatory submissions and addressing responses during regulatory reviews. • Train, coach, and guide lower-level employees on more complex procedures. Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may