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Edwards Lifesciences

Develops transcatheter heart valves and devices

Senior Engineer - Supplier Development

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeIrvine, CA, USA

About the Job

Requirements

  • A bachelor's degree in engineering or a scientific field and 4 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.
  • Ability to travel up to 25% domestically and internationally.
  • On-site work is required.
  • 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.
  • Ability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of design for manufacturing (DFM), geometric dimensioning and tolerancing (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 such as in-vitro testing.

Responsibilities

  • 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 new product development (NPD), partnering with Research and Development, Quality, Operations, Supply Chain, and external suppliers to transform innovative designs into scalable manufacturing solutions.
  • Conduct reviews to ensure design for manufacturing considerations are incorporated into designs, including manufacturability, quality, reliability, scalability, and cost optimization 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 original equipment manufacturers (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.

Desired Qualifications

  • A master's degree in engineering and/or a Master of Business Administration (MBA).

About the Company

Edwards Lifesciences

Develops transcatheter heart valves and devices

Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.

Company size
10,001+
Company stage
IPO
Headquarters
Irvine, CA
Founded
1958

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