Engineer II, 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  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:
• Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Develop, update, and maintain technical content of risk management files
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Other incidental duties assigned by Leadership What you'll need (Required Qualifications):
• Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience or
• Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred Qualifications):
• CQE (Certified Quality Engineer), preferred
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
•…