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Edwards Lifesciences

Principal Manufacturing Engineer

Reposted Yesterday
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In-Office
Irvine, CA, USA
121K-171K Annually
Senior level
In-Office
Irvine, CA, USA
121K-171K Annually
Senior level
The Principal Manufacturing Engineer will lead the development of advanced manufacturing equipment and automation solutions for THV products, ensuring manufacturability and compliance from concept to production.
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Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our THV R&D NPD Engineering team, you will work closely with cross functional teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

The Principal Engineer will lead the development of advanced manufacturing equipment and automation solutions for a next‑generation Transcatheter Heart Valve (THV) product at Edwards Lifesciences. Embedded within the THV business unit at the earliest stages of development, this role designs and delivers complex electromechanical systems—integrating PLC‑based controls, SCADA, robotics, and industrial communications—from concept through readiness for production. Partnering closely with R&D, Process Engineering, and Manufacturing Engineering, the engineer shapes how the product will be built, inspected, and scaled well before commercialization, while retaining full internal technical ownership despite vendor involvement. This role is critical to ensuring manufacturability; automation, inspection, and regulatory compliance are intentionally designed into the product from inception, supporting patient safety and long‑term product success.

How you will make an impact:

  • SCADA & Control Systems: Design, develop, and maintain SCADA architectures supporting early‑stage through production equipment, including HMI development, alarms, data logging, diagnostics, PLC‑based control logic (primarily Allen‑Bradley), and system lifecycle management with OT cybersecurity best practices.

  • Robotics & Automated Systems: Design, integrate, and program industrial robotic systems (e.g., Universal Robots, FANUC, ABB, KUKA), including end‑of‑arm tooling, safety systems, workcell layouts, motion paths, and optimization of cycle time, accuracy, and repeatability for automated assembly, handling, or inspection.

  • Mechanical & Electrical Integration: Interpret and apply mechanical drawings, electrical schematics, control panel layouts, and P&IDs; support installation, commissioning, debugging, and qualification of complex machine systems; diagnose and resolve mechanical, electrical, controls, and instrumentation issues while ensuring compliance with CE, NFPA 70E, OSHA, and IEC/ISO standards.

  • Industrial Networking & Data Connectivity: Design, configure, and maintain industrial networks (EtherNet/IP, Profinet, Modbus TCP, DeviceNet); implement secure OT network architectures including switching, segmentation, and firewalls; enable data exchange between PLCs, SCADA, MES, and higher‑level data systems.

  • Project Execution & Technical Leadership: Lead equipment and automation projects from concept and feasibility through commissioning; develop functional specifications, control strategies, test plans, and risk assessments; collaborate with R&D, Manufacturing, Quality, IT, and vendors to deliver integrated solutions; provide technical guidance and knowledge transfer to engineers, operators, and maintenance teams.

  • Pre‑Commercial / Early Lifecycle Focus: Drive manufacturing and automation strategy during concept and feasibility phases; shape equipment architecture and automation approaches prior to process lock; develop solutions appropriate for Class III medical devices, balancing innovation with compliance and patient safety; operate effectively within Edwards’ stage‑gated development and design control framework without becoming documentation‑driven; demonstrate experience in roles that are not sustaining manufacturing, not transfer‑only, and not back‑end automation support.

What you’ll need (Required):

  • Bachelor's Degree in Engineering or Scientific field, with a minimum of 6 years of related experience, including either industry or industry/education 

  • Master's Degree or equivalent in Engineering or Scientific field, with a minimum of 5 years of related experience, including either industry or industry/education 

  • Ph.D. or equivalent in Engineering or Scientific field, with a minimum of 2 years of related experience, including either industry or industry/education 

What else we look for (Preferred):

  • Automation, Controls & SCADA Fundamentals: Strong proficiency with PLC programming (Ladder Logic, Structured Text) and hands‑on experience with SCADA/HMI platforms; solid understanding of machine‑to‑machine and machine‑to‑system communication, industrial protocols, and data flow architectures; ability to define how equipment should communicate, integrate, and scale within Edwards’ manufacturing ecosystem, even if not a full‑time controls programmer.

  • Robotics, Vision & Advanced Equipment: Demonstrated experience programming and integrating industrial robots; familiarity with vision systems (e.g., Cognex, Keyence); experience working with automated, high‑precision manufacturing or inspection equipment.

  • Mechanical & Electrical Aptitude: Solid understanding of mechanical systems, actuators, pneumatics, sensors, motors, drives, and control panels; strong electrical troubleshooting capability; working knowledge of safety PLCs and machine safety standards; experience with CAD Mechanical/Electrical tools or EPLAN preferred.

  • Networking, MES & IIoT Exposure: Knowledge of industrial networking, cybersecurity, and communication protocols; experience with MES, IIoT, or equipment data connectivity platforms preferred.

  • Process Development, Compliance & Validation: Experience developing manufacturing processes suitable for Class III medical devices; participation in or leadership of equipment validation, line readiness, transfer planning, and process capability development; ability to apply design controls, traceability, and change management rigor without becoming rigid or overly procedural.

  • Industry Background & Engineering Foundation: Medical device experience is beneficial but not required; strong candidates may come from automotive, robotics, advanced equipment manufacturing, or industrial automation; brings systems thinking, engineering rigor, and the ability to adapt fundamentals to regulated environments; credible with vendors and internal design teams.

  • Technical Leadership & Collaboration: Acts as a hands‑on technical leader and mentor; able to challenge assumptions, guide design decisions, and establish best practices; communicates risks, tradeoffs, and recommendations clearly across disciplines; highly collaborative with R&D, Process Engineering, Project Management, and external equipment vendors.

  • Execution, Problem Solving & Ways of Working: Strong analytical problem‑solving and root‑cause analysis skills; able to manage multiple projects in fast‑paced, ambiguous environments; demonstrates ownership, independent execution, and effective collaboration; brings a continuous improvement mindset (Lean, Six Sigma).

  • Work Environment & Logistics: Comfortable working on the production floor around machinery and electrical systems; able to lift equipment up to 40 lbs; on‑site five days per week; willing to travel (~5–10%) for equipment builds, commissioning, vendor integration, and line transfers across domestic and occasional international sites.

  • Candidate Profile Alignment: Deeply hands‑on, execution‑focused, and motivated by patient impact; comfortable operating early when answers are not yet clear; skilled at bridging innovation, manufacturability, and compliance; excited to help define how the product will ultimately be built, not just how it operates today.

  • Commitment to adhering to all company policies and requirements, including Environmental Health & Safety regulations, injury‑prevention practices, and environmental protection and pollution‑prevention measures within one’s area of responsibility.

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, the base pay range for this position is $121,000 to $171,000 (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.

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