Principal Engineer, Process Development

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 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 worldwide. 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 the structural heart valve portfolio. Responsibilities 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, 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. Oversee technology development and commercialization, managing project schedules, technical risks, mitigation, validation and implementation strategies, and a cross‑functional team. Facilitate stakeholder communication throughout design, build, validation, site transfer, and sustainment phases. Partner with the Tissue & Biotechnology Center of Excellence, New Product Development, New Product Introduction, 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 – parameter development, window characterization, process capability studies, and ongoing optimization for yield, throughput, and quality. Act as 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. Qualifications Bachelor’s degree in engineering or science. 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. Preferred Qualifications Advanced degrees and/or Lean Six Sigma Certification. Medical device industry experience. Experience with design, development, operation, and troubleshooting of laser systems including ultra‑short pulse, CO₂, fiber, and related technologies. Demonstrated experience with advanced automation, vision systems, data‑driven manufacturing, or AI‑enabled process control. Experience serving as a technical project lead with a track record of transferring complex manufacturing or laser‑based 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 ongoing partnership for equipment delivery from concept through factory acceptance testing, site acceptance testing, 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. Compensation and Benefits For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced). Compensation will also include performance‑based incentives and a wide variety of benefits programs to address employee and family needs. Equal Opportunity Employer Edwards Lifesciences is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement All patient‑facing and in‑hospital positions require COVID‑19 vaccination. If hired into a covered role, a condition of employment is submission of proof of vaccination, unless a medical or religious accommodation is granted. This requirement does not apply where it is prohibited by law. #J-18808-Ljbffr Edwards Lifesciences Gruppe