Principal Manufacturing Engineer

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 nextgeneration 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 systemsintegrating PLCbased controls SCADA robotics and industrial communicationsfrom 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 longterm product success.

How you will make an impact:

• SCADA & Control Systems:Design develop and maintain SCADA architectures supporting earlystage through production equipment including HMI development alarms data logging diagnostics PLCbased control logic (primarily AllenBradley) 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 endofarm 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 higherlevel 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.

• PreCommercial / 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 stagegated development and design control framework without becoming documentationdriven; demonstrate experience in roles that are notsustaining manufacturing not transferonly and not backend automation support.

What youll need (Required):

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

• Masters 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 2years 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 handson experience with SCADA/HMI platforms; solid understanding of machinetomachine and machinetosystem 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 fulltime 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 highprecision 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 handson 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 problemsolving and rootcause analysis skills; able to manage multiple projects in fastpaced 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; onsite five days per week; willing to travel (510%) for equipment builds commissioning vendor integration and line transfers across domestic and occasional international sites.

• Candidate Profile Alignment:Deeply handson executionfocused 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 injuryprevention practices and environmental protection and pollutionprevention measures within ones 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 $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.