R&D Principal Engineer - Electrophysiology

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

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R&D Product Development

R&D Mechanical Engineering

Scientific/Technology

Irvine, California, United States of America

Johnson & Johnson is hiring for an R&D Principal Engineer – Electrophysiology to join our team located in Irvine, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

The R&D Principal Engineer will lead the R&D work‑stream on life cycle management (LCM) projects that will primarily focus on cost improvements. This individual will work with other engineers and cross‑functional partners in supporting existing product improvement, own Design History Files for LCM projects, own Design Requirements and ensure the design and design’s validated state complies with technical, quality, and regulatory compliance.

• 8 to 10 years of experience, preferably related to the position.
• University/Bachelor’s Degree in Engineering or Equivalent.
• Master’s Degree or greater is preferred.
• Strong knowledge of the medical device industry and manufacturing technologies.
• Familiarity with quality and regulatory systems including FDA’s Quality System Regulation, ISO
  13485, etc.
• Must have extensive experience in leading projects, developing processes, test methods, and documentation writing.
• Experience with tools and equipment for product design and manufacturing.
• Demonstrated experience developing technological solutions for medical device products.
• Proficiency in SOLIDWORKS and Design of Experiments (DOE).
• Familiarity with design control, engineering change orders (ECO), Corrective Actions and Preventative Actions (CAPA).
• Ability to operate independently and adapt to changing requirements.
• Ability to work in a fast‑paced environment, managing multiple priorities from different projects.
• Ability to travel 25% – 35% (Domestic and International).

Coaching, Contract Management, Critical Thinking, Design Thinking, Fact‑Based Decision Making, Feasibility Studies, Incident Management, Mechanical Engineering, Organizing, Process Oriented, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Vendor Management.

Coaching, Contract Management, Critical Thinking, Design Thinking, Fact‑Based Decision Making, Feasibility Studies, Incident Management, Mechanical Engineering, Organizing, Process Oriented, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Vendor Management.

$ – $

Independent of other compensation, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long‑term incentive program. Employees are eligible for the following time‑off benefits:
Vacation – 120 hours per calendar year;
Sick time – 40 hours per calendar year (increases to 48 hours in Colorado and 56 hours in Washington);
Holiday pay, including Floating…