Principal Engineer, NPD Quality

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 Engineer, NPD Quality, position is a unique career opportunity that could be your next step toward an exciting future.

Imagine how your ideas and expertise can change a patient's life. Our New Product Development Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross‑functionally with Manufacturing, Clinical, Regulatory, and R&D teams, delivering thoughtful solutions to complex challenges while expanding your knowledge of the medical device industry.

** You Will Make an Impact By:*
* + Applying knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures for new product development.

+ Providing leadership and oversight for devices, systems, or projects to develop, update, and maintain design control throughout the product development lifecycle; supporting the creation and refinement of design requirement documentation.

+ Developing, updating, and maintaining the technical content of risk management and usability files.

+ Leading the identification, development, and optimization of complex Manufacturing and/or R&D processes using engineering methodologies (e.g., Six Sigma, Lean) to support DFM and continuous improvement initiatives.

+ Identifying opportunities and implementing solutions for the design or redesign of complex equipment, new technologies (including automation and software), tools, fixtures, and related components to enhance manufacturing processes and/or test methods and reduce overall process and product risk.

+ Driving the development and managing the execution of complex experiments and tests, including writing and executing protocols, to create, validate, and improve products; evaluating source materials and suppliers; and establishing robust processes and test methods grounded in engineering principles.

+ Ensuring completion of usability studies, design verification and validation, and process/test method validations, including analyzing data and generating comprehensive reports.

+ Collaborating with cross‑functional partners to support project success and ensure on‑time completion of deliverables.

+ Leading investigations into complex product quality and compliance issues (e.g., pre‑commercial complaints, CAPA, non‑conformances, audit observations, PRAs) during new product development; analyzing results, making recommendations, and generating reports.

+ Serving as a subject matter expert during internal and external audits for products and/or processes; supporting regulatory submissions and addressing regulatory inquiries.

+ Training, coaching, and guiding junior engineers and technicians on advanced procedures; overseeing Quality support tasks; providing instruction on test execution; and coordinating work as needed.

+ Performing other incidental duties as assigned.

** What You'll Need (Required):*
* + Bachelor's degree in Engineering or a Scientific field and 6 years of related experience, including either industry or industry/education; OR

+ Master's degree or equivalent in Engineering or a Scientific field and 5 years of related experience, including either industry or industry/education; OR

+ Ph.D. or equivalent in Engineering or a Scientific field and 2 years of related experience, including either industry or industry/education.

** What Else We Look For (Preferred):*
* + Proven expertise using the MS Office Suite; CAD experience preferred.

+ Excellent documentation, communication, and interpersonal relationship skills, including negotiation and relationship management.

+ Ability to translate complex technical information to all levels of the organization.

+ Extensive knowledge of engineering principles, theories, and concepts relevant to the role.

+ Advanced problem‑solving,…