Senior Principal Engineer, THV R&D

Edwards Lifesciences; Irvine (CA); On-site; USD 139,000 - 196,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Principal Engineer, R&D to lead the design and development of next-generation access technologies from concept to commercialization, working with Quality and Manufacturing to address unmet clinical needs and improve patient outcomes.

This role partners with cross-functional teams to drive manufacturing transfer, verification testing, and robust design strategies, while mentoring engineers and advancing technical excellence across the Access

Qualifications

• Bachelor's degree with 8+ years of related experience
• Master's degree with 7+ years of related experience
• Minimum of 5 years of medical device product and/or process development experience

Responsibilities

• Drive the technical development of a next-generation expandable sheath, including Design for Manufacturing considerations, through all phases of the Design Control process while serving as the technical subject matter expert.
• Lead the development of product and component specifications.
• Develop and execute design verification strategies and testing plans, including biocompatibility activities.
• Represent the Access R&D team with internal technical partners and senior business leadership.
• Develop and implement long‑term strategies for deploying innovative design solutions within the Access platform.
• Partner with Process Development and Manufacturing teams to transfer new designs into commercial production.
• Guide and mentor engineers in solving complex technical challenges.
• Promote technical excellence and knowledge sharing across teams and functions.

Skills

Design for Manufacturing

Design verification

3D modeling

Cross-functional collaboration

Technical leadership

Education

Bachelor's degree in Engineering or related field

Master's degree in Engineering or related field

Tools

CAD software

Job description

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, the Senior Principal Engineer, R&D will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. You will lead the technical design and development of next-generation access technologies throughout the product lifecycle, from concept through commercialization, partnering with cross-functional teams to achieve key clinical, technical, and commercial milestones.

How you'll make an impact:

• Drive the technical development of a next-generation expandable sheath, including Design for Manufacturing considerations, through all phases of the Design Control process while serving as the technical subject matter expert.
• Lead the development of product and component specifications.
• Develop and execute design verification strategies and testing plans, including biocompatibility activities.
• Represent the Access R&D team with internal technical partners and senior business leadership.
• Develop and implement long‑term strategies for deploying innovative design solutions within the Access platform.
• Partner with Process Development and Manufacturing teams to transfer new designs into commercial production.
• Guide and mentor engineers in solving complex technical challenges.
• Promote technical excellence and knowledge sharing across teams and functions.

What you'll need (Required):

• Bachelor's degree in Engineering or related technical field with 8 years of relevant experience required, OR Master's degree in Engineering or related technical field with 7 years of relevant experience required.
• Minimum of 5 years of medical device product and/or process development experience.

What else we look for (Preferred):

• Proven track record leading product and process development projects from concept through commercialization.
• Demonstrated ability to establish technical strategies and execute against complex development objectives.
• Proven project leadership experience.
• Ability to identify, assess, and mitigate technical and program risks.
• Experience creating component and assembly drawings and 3D models.
• Experience designing for manufacturing processes such as plastic extrusion, injection molding, and joining technologies.
• Experience leading engineering testing and design verification activities.
• Strong problem-solving, analytical, organizational, and critical‑thinking skills.
• Excellent written, verbal, and technical communication skills.
• Ability to influence cross‑functional teams, business units, and manufacturing sites.
• Ability to interact effectively across all organizational levels and appropriately elevate issues when needed.

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.

For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).