Senior 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 Senior 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 developing your knowledge of the medical device industry.

• Developing, updating, and maintaining design control documentation throughout product development processes, and supporting the creation of design requirement documentation.
• Developing, updating, and maintaining the technical content of risk management and usability files.
• Collaborating with R&D, Manufacturing, and cross‑functional stakeholders to drive process and test method development, product builds, clinical programs, design transfer, and product launch; participating in design verification and validation testing.
• Investigating 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 developing reports.
• Identifying and optimizing complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma, Lean) to support design for manufacturing and continuous improvement; identifying opportunities to redesign or design equipment, tools, and fixtures to improve manufacturing processes, test methods, and reduce risk.
• Assigning support tasks; providing instructions to technicians on test execution; training technicians and offering feedback; and coordinating technician work. Also training, coaching, and guiding lower‑level employees on routine procedures.
• Performing other incidental duties as assigned by Leadership.

• Bachelor’s Degree in Engineering or a Scientific field with 4 years of related industry experience; OR
• Master’s Degree or equivalent in Engineering or a Scientific field with 3 years of related industry experience; OR
• Ph.D. or equivalent in Engineering or a Scientific field with industry or industry/education experience.

• Proven expertise using the MS Office Suite, including MS Project; CAD experience preferred (as applicable).
• Strong documentation, written and verbal communication, and interpersonal/consultative relationship‑building skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab or industrial equipment (as applicable).
• Substantial understanding of engineering principles, theories, and concepts.
• Strong problem‑solving, organizational, analytical, and critical‑thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Strong leadership skills with the ability to influence change.
• Knowledge of applicable FDA regulations for the medical device industry.
• High attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast‑paced environment.
• Ability to work effectively in a team environment, including interdepartmental teams, and serve as a key contact representing the organization on contracts or projects.
• Commitment to adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and taking appropriate measures to prevent injuries and protect the environment within one’s area of influence.

Aligning our overall business objectives with performance, we offer competitive salaries, performance‑based incentives, and a wide variety of benefits programs to address the diverse individual needs…