Principal Manufacturing Engineer

Edwards Lifesciences • Irvine, CA

19h • Onsite

About The Position

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

Requirements

• 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

Nice To Haves

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

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees