Senior Engineer, New Product Development

Edwards Lifesciences • Irvine, CA

2d • $107,000 - $127,000

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 position is a unique career opportunity that could be your next step towards an exciting future. Join our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit as a Principal NPD Engineer to boldly pursue an innovative portfolio of technologies for patients with complex heart valve disease. In this exciting New Product Development (NPD) role, you will contribute from Early Human Use through commercialization, developing and optimizing manufacturing processes focused on addressing unmet clinical needs. You will work in high collaboration with R&D, Pilot, and commercial manufacturing teams, joining an inspiring journey to help patients live longer, healthier lives.

Requirements

• Bachelor’s Degree in Engineering or Scientific field with a minimum of 4 years related experience, including either industry or industry/education or Master's Degree or equivalent in Engineering or Scientific field with a minimum of 3 years related experience, including either industry or industry/education or Ph.D. or equivalent in Engineering or Scientific field with either industry or industry/education

Nice To Haves

• Proven expertise with MS Office Suite; CAD experience preferred.
• Excellent documentation, written and verbal communication skills, with strong interpersonal and relationship‑building abilities.
• Ability to translate technical information effectively to various levels of the organization.
• Solid understanding of engineering principles, theories, and concepts relevant to the role.
• Strong problem‑solving, analytical, organizational, and critical‑thinking skills.
• Substantial understanding of processes, equipment, and tools used within assigned work areas.
• Demonstrated ability to work with lab or industrial equipment, as applicable.
• Working knowledge of statistical techniques used in manufacturing and process evaluation.
• Strong leadership skills with the ability to influence, collaborate, and drive change across teams.
• Knowledge of applicable FDA regulations and quality system requirements within the medical device industry.
• Strict attention to detail and commitment to high‑quality work output.
• Ability to interact professionally across all organizational levels.
• Ability to manage competing priorities in a fast‑paced environment.
• Proven ability to work effectively in team environments, including cross‑functional and interdepartmental groups.
• Ability to represent the organization effectively when providing technical input or supporting project teams.
• Commitment to adhering to all company rules, including Environmental Health & Safety requirements, and actively contributing to injury prevention, environmental protection, and pollution prevention within span of control.

Responsibilities

• Support and drive complex design control activities related to manufacturing products and processes with commercialization readiness in mind.
• Develop and maintain complex manufacturing documentation (drawings, SOPs, routers, pFMEA) across multiple release stages.
• Conduct drawing reviews and ensure tolerance stack‑up compliance aligned with manufacturing capabilities.
• Perform fit testing of design components and fixtures to ensure alignment with Pilot and Commercial manufacturing expectations.
• Execute and assist in defining manufacturing process requirements and process controls by evaluating new and existing standards.
• Apply DFx principles, tolerancing, material selection considerations, and automation readiness to guide specification development.
• Contribute to the establishment of stability metrics and support risk elevation/mitigation through SCRR and MRR activities.
• Use Voice of the Factory insights and SME manufacturing knowledge to identify, recommend, and support process improvements and standardization.
• Identify, define, and support implementation of design and process improvements that enhance manufacturability and reduce production risk.
• Drive and support line and build strategy development, prioritization, and technical issue resolution for QST, pre‑DV, and DV builds.
• Partner closely with Pilot Manufacturing to investigate and resolve root cause issues prior to commercialization.
• Develop and/or execute complex experiments and test protocols to characterize and refine manufacturing processes.
• Drive and/or perform manufacturing process qualifications and validations (IQ, OQ, and software‑related), providing guidance to junior engineers and technicians.
• Collaborate on the development of manufacturing equipment engineering and tooling design for program‑specific needs.
• Support analysis and resolution of Manufacturing and Compliance issues, including CAPAs, non-conformances, and audit observations.
• Identify opportunities to redesign or improve equipment, tools, and fixtures to optimize manufacturing performance.
• Improve manufacturing processes using engineering methods such as LEAN principles and basic statistical approaches.
• Support and execute process transfer activities to ensure smooth pathway from development to Pilot and Commercial Manufacturing.
• Collaborate with R&D, Pilot, Commercial Manufacturing, and suppliers to support redesign opportunities and change notifications aligned with design intent.
• Follow project plans and use project management tools (e.g., schedule tracking, risk analysis) to ensure deliverables meet expectations.
• Provide day‑to‑day technical guidance to technicians and junior engineers to support development activities and manufacturing readiness.
• Perform 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: Mid Level
• Number of Employees: 5,001-10,000 employees