Principal Engineer, Process Development

Imagine how your ideas andexpertisecan change a patients life. Our GlobalOperations &Qualityteam plays a central part in ensuring our products are delivered to patients with cardiovascular 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 youll make an impact:

• Serve as a senior technical authority for advanced tissue manufacturing and laserbased 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 youll need:

• Bachelors 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 ultrashort pulse CO₂ fiber and related laser technologies.

• Demonstrated experience with advanced automation vision systems datadriven manufacturing or AIenabled process control.

• Experience serving as a technical project lead with a track record of successfully transferring complex manufacturing or laserbased technologies across sites or product lines.

• Strong financial acumen related to capital equipment budget and operating expense management and cost-benefit analysis.

• Demonstrated technical leadership in the end-to-end equipment design and development process including defining equipment and software requirements driving system architecture and detailed specifications and ensuring alignment with manufacturing and regulatory needs.

• Proven experience managing external vendors through selection qualification and on-going partnership for equipment delivery from concept through factory acceptance testing (FAT) site acceptance testing (SAT) commissioning validation and production readiness.

• Demonstrated expertise in manufacturing process development optimization and validation of complex equipment or laser-based processes including authoring and executing characterization IQ/OQ/PQ and equipment technical documentation in compliance with regulatory requirements.

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 $121000 to $171000 (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.