R&D Engineer II Electrophysiology

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech 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 more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Fueled by innovation at the intersection of biology and technology were 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 thats 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. Learn more at are searching for the best talent for a R&D Engineer 2 to support our Electrophysiology business. This role will work onsite in our Irvine CA office.

A Level 2 R&D Mechanical Engineer contributes to the design development verification and transfer-to-manufacturing of electrophysiology (EP) and ultrasound catheter products. The role works on cross-functional project teams to deliver safe reliable and manufacturable catheter shafts steerable mechanisms and miniaturized ultrasound transducer assemblies used in EP or Structural Heart procedures.

Key Responsibilities

• Design and develop mechanical components and assemblies for medical devices using SolidWorks (3D modeling and detailed drawings).
• Actively contributes to the definition and development of innovative patents.
• Support design control activities: requirements decomposition design verification and validation planning/execution and Design History File documentation.
• Plan and execute engineering characterization: develop test fixtures instrument systems collect/analyze mechanical/electrical/acoustic data and prepare technical characterization reports.
• Support verification testing and system integration: develop/execute verification plans and protocols assist with test setup/troubleshooting validate mechatronic and softwarehardware interactions and document results.
• Perform tolerance analysis tolerance stack-ups and tolerance optimization for manufacturability and assembly.
• Conduct engineering analyses: basic FEA control/dynamic assessments material selection and fluid/mechanical performance evaluations.
• Develop prototypes lead bench testing iterate designs based on test results and usability feedback and support automated test fixture development.
• Participate in risk management activities: identify hazards support FMEAs and implement mitigations addressing mechanical electrical related risks.
• Support engineering change requests and provide technical input for supplier qualification and production ramp.
• Collaborate with manufacturing supply chain quality regulatory and clinical teams to support transfer-to-production and process validation.
• Support supplier technical evaluations and provide technical direction during supplier qualification and production ramp.

Required Qualifications

• BS in Mechanical Engineering Biomedical engineering or related engineering discipline.
• Experience:
  • With a BS and prior medical device experience: 24 years of industry product development experience.
  • With a BS and experience in another regulated industry (e.g. pharmaceutical aerospace automotive defense): 4 years of industry experience.
  • With an MS: may substitute for 12 years of experience.
• Familiarity with design controls verification/validation processes and risk management in regulated environments.
• Hands-on bench-testing experience
• Proficiency in 3D CAD (SolidWorks) and creation of detailed drawings with GD&T.
• Fundamental understanding of mechanical mechanisms
• Strong problem-solving data analysis and communication skills; proven ability to work in cross-functional teams.

Preferred Qualifications

• Prior hands-on experience prototyping with intracardiac/vascular EP catheters ultrasound imaging catheters or minimally invasive delivery systems.
• Experience designing articulating shafts for minimally invasive catheters.
• Experience supporting or leading the design of a medical device component or assembly
• Experience identifying critical design requirements then characterizing and documenting the requirement.
• Experience using Minitab or similar statistical software for analysis
• Familiarity with Six Sigma Methodology for problem solving.
• Experience working on early stage conceptual design projects

Nice to have

• Knowledge of Product Development Process
• Experience developing fixtures and test methods
• Experience with PLM systems (Windchill)
• Experience with FEA software such as ANSYS or COMSOL.
• Exposure to receiving and translating clinical requirements to prototypes

Core Competencies

• Catheter mechanics micro-device assembly and mechatronic integration mindset
• Systems thinking across mechanical electrical and software domains
• Cross-functional collaboration and supplier engagement
• Attention to detail with strong documentation discipline
• Data-driven decision making and root-cause analysis
• Project and time management; ability to meet milestones under moderate supervision

Working Conditions

• Office lab and cleanroom-adjacent environments with hands-on prototype work
• Work with bench test equipment small tools and electromechanical fixtures; adherence to safety and cleanroom protocols required
• Occasional travel to suppliers contract manufacturers or clinical sites may be required

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via Internal employees contact AskGS to be directed to your accommodation resource.

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