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Principal Engineer, Process Development

Job in Irvine, Orange County, California, 92604, USA
Listing for: Edwards Lifesciences
Full Time position
Listed on 2026-07-01
Job specializations:
  • Engineering
    Process Engineer, Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Imagine how your ideas and expertise can change a patient's life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes technical engineering, strategic business planning, process innovation, product compliance, supplier management, or enabling supply chain operations, you will be making a meaningful contribution to our team and to patients all over the world.

Innovation starts from the heart. Heart valve disease impact millions of lives, spanning all ages and geographies. As communities globally address the opportunities and challenges of cardiovascular care, telling a compelling and authentic story is more crucial than ever.  At Edwards Lifesciences, our Manufacturing and Engineering teams develop tools, technologies, and processes to power the production of life-changing medical devices to transform patients' lives.

Within the Tissue Process Engineering Group, this position serves as a technical contributor and project lead, supporting the development, deployment, and optimization of advanced tissue manufacturing processes for structural heart valve portfolio.

** How you'll make an impact:*
* + Serve as a senior technical authority for advanced tissue manufacturing and laser‑based process technologies across the Edwards Implant Network.

+ Lead technology projects from concept through implementation, including prototyping and characterization, system architecture and requirements definition, vendor selection and management, , system commission, , site transfer, and production ramp-up.

+ Lead the development, evaluation, and integration of complex tissue process technologies into new product development and manage lifecycle improvements.

+ Serve as the technical project lead overseeing technology development and commercialization, with responsibility for project schedules, managing technical risks and mitigation, developing validation and implementation strategies, leading a cross-functional team, and facilitating stakeholder communication throughout design, build, validation, site transfer, and sustainment phases.

+ Partner closely with the Tissue & Biotechnology Center of Excellence (T&BCOE), New Product Development (NPD), New Product Introduction (NPI), Quality, Regulatory, Validation, suppliers, and global manufacturing sites to translate design intent and Voice of the Factory into robust tissue manufacturing and laser process solutions.

+ Design and execute, complex experiments and validation strategies to qualify tissue manufacturing technologies in a highly regulated environment.

+ Apply principles of biomechanics to mechanical design, automation, and technologies, such as , laser and optical systems, chemical processing, vision systems, artificial intelligence, and data analytics to advance tissue manufacturing capability.

+ Own laser process development activities including parameter development, window characterization, process capability studies, and ongoing optimization for yield, throughput, and quality.

+ Act as a mentor and technical coach to engineers and technicians, elevating organizational capability in tissue processing and laser technologies.

+ Promote safety, ergonomic, laser safety, and automation best practices in the design and implementation of tissue process solutions.

** What you'll need:*
* + Bachelor's degree in engineering or scientific with 6 years of engineering experience including technology site transfers in a highly regulated environment.

+ Experience working with laser equipment.

+ Travel up to 25% domestically and internationally.

+ Onsite required.

** What else we look for:*
* + Advanced degrees and/or Lean Six Sigma Certification.

+ Medical device industry.

+

Experience with design, development, operation, and troubleshooting of laser systems including ultra‑short pulse, CO₂, fiber, and related laser technologies.

+ Demonstrated experience with advanced…
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