Senior Engineer, NPD Quality

Edwards Lifesciences • Irvine, CA

1d • $108,000 - $153,000

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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 of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior