Senior Principal Engineer, THV R&D

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

Job summary

Edwards Lifesciences Gruppe in Irvine, CA, is seeking a Senior Principal Engineer, R&D to drive the technical development of next-generation access technologies from concept to commercialization. You will lead design, verification, and manufacturing transfer while guiding cross-functional teams to meet critical milestones.

Applicants should have 8+ years in medical device product or process development, with strong problem-solving and communication skills.

Qualifications

• 8+ years of relevant experience in medical device product or process development.

Responsibilities

• Lead the technical design and development of next-generation access technologies from concept through commercialization.
• Develop and execute design verification strategies and testing plans.
• Partner with Quality and Manufacturing teams to transfer designs into production.
• Mentor engineers and drive cross-functional technical excellence.

Skills

Design for Manufacturing

Project leadership

Cross-functional collaboration

Problem solving

Technical communication

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

3D CAD

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 l ead 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.Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.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 escalate 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). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.