R&D Staff Engineer

Johnson & Johnson Innovative Medicine • Irvine, CA

1d • $109,000 - $174,800 • Onsite

About The Position

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. Your unique talents will help patients on their journey to wellness. We are searching for the best talent for a R&D Staff Engineer to support our Electrophysiology business. This role will work fully on-site in our Irvine, CA office. Primary Function of Position The Staff R&D Engineer is responsible for the technical development of therapeutic systems at J&J Medtech Electrophysiology. Their focus will be on the mechanical/electrical design of advanced energy catheters and accessories, contributing to the advancement of both our therapeutic and diagnostic systems. They will be a responsible member of the R&D team supporting innovative technology development and commercialization. They will have both the technical depth to resolve complex mechanical, material, and manufacturing design issues as well as the ability to work in an interdisciplinary team to troubleshoot and root cause higher level system issues. They must have strong technical depth in relevant areas and have a track record of successful product development efforts. Using their subject matter expertise, exceptional communication skills and cross-functional collaboration, they will investigate and develop catheters and/or accessories that are part of our therapeutic and diagnostic EP ecosystem. They must excel in a high-energy, focused, small-team environment, and have a commitment to high quality prototypes and concepts. A strong sense of shared responsibility and shared reward is required as well as a commitment to high product quality.

Requirements

• A minimum of 6-8 years of relevant experience with a Bachelors degree, minimum of 4-6 years with a masters
• Demonstrated ability to work in cross-functional research and development teams
• Experience with FDA QSR 21 CFR Part 820, ISO 13485 and other related standards
• Demonstrated ability to originate novel concepts and rapidly convert ideas into functional prototypes to evaluate technical feasibility and clinical value
• Proven track record operating in highly ambiguous environments with limited data, effectively identifying key risks and prioritizing experiments to accelerate learning
• Strong capability to define early product architecture and translate feasibility prototypes into scalable, design-controlled development programs
• Demonstrated ability to determine what to prototype versus what to analyze, balancing speed, risk reduction, and long-term scalability
• Expertise in structured problem-solving and rapid design iteration cycles (build–test–learn)
• Hands-on experience with rapid prototyping methods including 3D printing, plastics processing, metal fabrication, and bench-level assembly
• Proficiency in CAD-based mechanical design (SolidWorks preferred)
• Experience with all phases of the product development lifecycle; including proof-of-concept, design, implementation, debug, verification, qualification, and transfer
• High autonomy and ability to work independently under limited supervision to determine and develop approach to solutions.
• Ability to communicate effectively (written, oral) across all levels and organizations
• BS or MS in Mechanical Engineering, or related engineering or scientific discipline, or equivalent work experience

Nice To Haves

• Experience with energy delivery devices is a strong plus

Responsibilities

• Work in a small, cross-functional project team to design, develop and verify new catheters/cables.
• Develop, implement, test and document new solutions, processes, and designs according to corporate standards and departmental operating procedures
• Hands-on assembly and testing of devices to support proof of concept, design development, pre-clinical and V&V activities
• Investigate and determine root cause of emerging design or manufacturing defects/failures.
• Develop product concepts and assess with physicians and healthcare staff, identifying feature set, use conditions, design requirements/specifications, and completing tradeoff analysis.
• Development and documentation of design and manufacturing documentation including inspection procedures, assembly instructions, test methods, purchase specifications, BOMs, part and assembly drawings using appropriate change control procedures
• Establish individual goals consistent with overall project goals
• Performs other duties as required to support the company's overall strategy and goals

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior