Principal Engineer, Process Development (Lasers & Optics)

Edwards Lifesciences•Irvine, CA

8d•$121,000 - $171,000•Onsite

About The Position

This position serves as a technical contributor and workstream lead within the Tissue Process Engineering Group, supporting the development, integration, deployment, and optimization of advanced tissue manufacturing and laser-based processes for the structural heart valve portfolio. The role involves partnering cross-functionally with manufacturing operations and sales teams to deliver solutions to complex challenges within the medical device industry. The company focuses on transforming patients' lives through the production of life-changing medical devices for cardiovascular care.

Requirements

Bachelor's degree in Physics, Mechanical Engineering, Electrical Engineering, or a related engineering or scientific field.
6 years of engineering experience, including technology development or site transfer in a highly regulated environment.
Hands-on experience designing, integrating, characterizing, or troubleshooting laser and optical systems.
Travel up to 25% domestically and internationally.
Onsite required.

Nice To Haves

Advanced degree in Optical Engineering, Photonics or a related technical field
Lean Six Sigma certification.
Experience in the medical device industry or another highly regulated manufacturing environment.
Plan and execute optical verification using appropriate diagnostics and metrology, such as beam profiling, power and energy measurement, pulse characterization, imaging performance, focus verification, and calibration studies.
Demonstrated experience with optical components and subsystems such as beam delivery, scanners, focusing optics, cameras, illumination, sensors, metrology, machine vision, and automated alignment or calibration.
Experience with optical design and analysis tools such as Zemax OpticStudio, CODE V, or equivalent ray-tracing software, including tolerance analysis and design for manufacturability.
Experience serving as a technical project lead with a track record of successfully 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 end-to-end custom equipment development, including defining user, system, software, and interface requirements; driving system architecture and detailed specifications; and ensuring alignment with manufacturing and regulatory needs.
Proven experience managing equipment suppliers through selection, technical reviews, qualification, and ongoing partnership from concept through factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, validation, and production readiness.

Responsibilities

Serve as a technical authority for advanced tissue manufacturing, laser processing, and optical systems integration across the Edwards Implant Network.
Lead technology project workstreams from concept through implementation, including definition of system hardware and software architecture, prototyping and characterization, user requirements/equipment specification definition, vendor selection and management, commissioning, site transfer, and production ramp-up.
Develop and maintain system architecture, interface definitions, alignment tolerances, parameter windows, and subsystem specifications for optics and/or laser-based equipment.
Support the development, evaluation, and integration of complex tissue process technologies and equipment into new product development programs and/or commercial manufacturing and manage lifecycle improvements.
Support the technical project lead overseeing technology development and commercialization, with contributions to project schedules, managing technical risks and mitigation, developing validation and implementation strategies, working in 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 (TABCOE), 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 (VoF) into robust tissue manufacturing processes, which includes laser and optical system solutions.
Conduct optimization, and validation of complex equipment or laser-based processes, including authoring and executing characterization studies, IQ/OQ/PQ, and subsequent technical documentation in compliance with regulatory requirements.
Design and execute complex experiments, characterization studies, and develop validation strategies to qualify tissue manufacturing technologies in a highly regulated environment.
Diagnose and troubleshoot equipment issues; identify and document root cause and appropriate corrective action.
Apply principles of optics, optomechanical design, mechanical, electro-mechanical design, automation, vision systems, artificial intelligence, and data analytics to advance tissue manufacturing capability.
Own laser and optical process development activities, including, parameter development, process window characterization, alignment and calibration, 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 ergonomic, laser safety, and automation best practices in the design and implementation of tissue process solutions.