Edwards Lifesciences

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. In addition, patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs.

The Senior Principal Engineer will work polymer-based products (extrusion and catheters) suppliers and cross functional teams on the commercial scale-up and sustaining the Edwards Transcatheter Heart Valves (THV) and Transcatheter Mitral Tricuspid Therapies (TMTT) delivery systems. The Principal Engineer will serve in a technical leadership role and collaborate closely with key internal and external stakeholders to ensure the design meets user needs, including but not limited to device ease of use, manufacturability, cost effectiveness, and operations efficiency. In addition to technical responsibilities, the Principal Engineer will use strong project management skills and a deep knowledge of Design Control and Part Qualification to ensure effective project implementation.

How you’ll make an impact:

• Lead efforts on the cross functional team to generate, review, and approve drawings and design control documentation.
• Apply sound engineering principles and practices to the design and testing of medical devices.
• Support suppliers and internal test plans, protocols, and reports. Analyze and present results, applying statistical analysis as necessary.
• Work with and provide oversight to suppliers on the design and procurement of components, tooling and fixtures for the design, testing, inspection or assembly of products.
• Generate prototypes, evaluate and make recommendations on concepts and design modifications based on key stakeholder feedback.
• Interface with R&D, operations, marketing, regulatory and supply chain stakeholders to design for manufacturability and cost improvement strategies.
• Support design control review meetings to ensure completion of required project deliverables, and coordinate follow up activities with cross functional team members on action items.
• Lead or facilitate technical update meetings and reviews with R&D, operations, marketing and regulatory.
• 25% travel domestically.
• Perform other duties and responsibilities as assigned.

What you’ll need:

• Bachelor’s degree in engineering or scientific.
• Minimum of 8 years of experience in medical device mechanical design.
• Experience in catheter design and manufacturability with a variety of materials including plastics and alloys.
• Possess a successful track record of medical device product development from concept through launch.
• Experience in the use of statistical tools (SPC, Six Sigma, DMAIC, etc.).
• On-site work required.

What else we look for:

• Master’s degree in mechanical engineering, biomedical engineering.
• Black Belt certification.
• SME in one or more of the following: Polymer, Injection Molding, Catheter technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
• In-depth experience of Design Control requirements and experience generating documentation including Part Qualification Plan, Design Requirements, Risk Management, Design Verification and Validation.
• Experience in CAPA elements and implementation.
• Technical team leadership capability with strong self-motivation, project management skills, and demonstrated ability to lead a cross functional team while optimizing resources to deliver project results.
• Ability to work on complex problems and projects where analysis of situation or data requires an in-depth, solid understanding of engineering principles.
• Effective verbal/written communication and interpersonal skills including conflict and relationship management.

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 $136,000 to $192,000 (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.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.