Senior Engineer, Supplier Development

Posted 2 Days Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
108K-153K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Lead supplier development and manufacturing integration for transcatheter mitral and tricuspid devices from concept to launch. Ensure designs are manufacturable, cost-effective, and compliant; define supplier qualification and validation strategies; drive technical governance, risk management, technology transfers, process optimization, and cross-functional collaboration to enable scalable, reliable production.
Summary Generated by Built In

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. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Senior Engineer will serve as a technical subject matter expert, partnering closely with internal teams and external suppliers to ensure product designs meet user needs - including ease of use, manufacturability, cost effectiveness, and operational efficiency. In addition to technical engineering capabilities, this role requires strong project management capabilities and a thorough understanding of Design Control and Catalyst processes to drive effective, compliant, and timely project execution.

How you’ll make an impact:

  • Lead the successful commercialization of next-generation medical devices by driving supplier development, validation, milestone builds, and manufacturing integration from concept through product launch.

  • Serve as a key technical leader in NPD, partnering with R&D, Quality, Operations, Supply Chain, and external suppliers to transform innovative designs into scalable manufacturing solutions.

  • Conduct reviews to ensure DFM considerations are incorporated into designs, ensuring manufacturability, quality, reliability, scalability, and cost optimization are incorporated early in the development process.

  • Drive technical collaboration with strategic suppliers to develop advanced manufacturing processes, evaluate emerging technologies, and enhance product and process performance.

  • Provide engineering guidance through design reviews, drawing reviews, risk assessments, and process capability evaluations to enable robust and reliable manufacturing outcomes.

  • Define supplier qualification and validation strategies for OEMs, contract manufacturers, custom materials, and critical component suppliers supporting global product portfolios.

  • Lead technical governance and engagement with key suppliers, driving performance, resolving complex challenges, and ensuring alignment on business-critical objectives.

  • Develop innovative manufacturing technologies and production strategies to support new products, improve operational efficiency, and accelerate commercialization timelines.

  • Conduct supplier assessments focused on technical capability, quality systems, capacity planning, and long-term scalability to support business growth.

  • Partner with suppliers and internal teams to optimize manufacturing processes, implement automation solutions, improve yield, and drive continuous improvement initiatives.

  • Champion successful technology transfers and design-to-manufacturing transitions, ensuring manufacturing readiness and sustainable production performance across global sites.

  • Lead supplier risk management, capacity planning, and mitigation strategies to support uninterrupted supply and successful product launches.

  • Provide technical leadership updates during supplier audits, product investigations, regulatory submissions, design changes, and post-market product enhancements.

  • Manage product lifecycle activities, including design changes, supplier transitions, product phase-in/phase-out initiatives, and regulatory-driven updates.

  • Influence long-term sourcing and manufacturing strategies through supplier selection, capability assessments, qualification planning, and deployment of best-in-class manufacturing practices.

What we look for:

  • Bachelor's degree in engineering or scientific, with 4 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.

  • Travel up to 25% domestically and internationally.

  • On-site work required.

What else we look for:

  • Master’s degree in engineering and/or MBA.

  • Experience in medical device new product development, including successful design optimization and progression from early development through commercialization.

  • Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.

  • Hands-on experience with catheter manufacturing processes, such as extrusions, braiding, molding, laser welding, and bonding techniques.

  • Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.

  • Technical skills in biomedical design and delivery system catheter design.

  • Ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.

  • Experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).

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 $108,000 to $153,000 (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.

Skills Required

  • Bachelor's degree in engineering or scientific discipline
  • Minimum 4 years' experience in new product development, process development, commercialization, or operations engineering in a regulated environment
  • Thorough understanding of Design Control and Catalyst processes
  • Strong project management capabilities
  • On-site work required
  • Willingness to travel up to 25% (domestic and international)
  • Master's degree in engineering and/or MBA
  • Experience in medical device new product development and commercialization
  • Background in interventional access devices, rapid product development, component-level manufacturing, or complex assembly design (at least two areas)
  • Hands-on experience with catheter manufacturing processes (extrusions, braiding, molding, laser welding, bonding)
  • Working knowledge of DFM, GD&T, and Six Sigma methodologies
  • Ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements
  • Experience with rapid prototyping, creative design iteration, and test method development (e.g., in‑vitro testing)

Edwards Lifesciences Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.

  • Healthcare Strength Health coverage is considered strong, with multiple plan choices, HSA options, and fertility support, and the company highlights holistic well‑being programs.
  • Retirement Support A company 401(k) match and well‑regarded retirement offerings add clear long‑term value to total compensation.
  • Equity Value & Accessibility An Employee Stock Purchase Plan with a discount and look‑back feature makes equity ownership accessible and enhances the total rewards package.

Edwards Lifesciences Insights

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The Company
HQ: Irvine, CA
13,687 Employees
Year Founded: 1958

What We Do

Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms

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