Job Function:
Supply Chain Engineering
Job Sub Function:
Mechanical Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Irvine, California, United States of America
Job Description:
Our J&J MedTech Electrophysiology Engineering team is currently recruiting for aSr. Principal Mechanical Engineer. The position is located in Irvine, California. This position will report on-site 5 days a week.
If you are an entrepreneurial innovator technical leader with a proven track record come join the HTI as a Senior Principal Engineer and take ownership of the next generation of catheter technologies that will redefine electrophysiology and cardiac care worldwide.
We are looking for people who have engineered disruptive devices, driven successful prototypes into clinical proof-of-concept, secured patents or led innovation within RnD. If you thrive on high-impact challenges, move fast, and want the freedom to invent at the intersection of science, engineering, and business, this role was built for you.
What you’ll own:
· Lead end-to-end innovation: identify and incubate high-potential concepts through proof-of-concept, and first human cases.
· Execute technically bold programs across materials, miniaturization, navigation, sensing, and next-gen catheter architectures.
· Build and lead innovation in a fast-paced incubator environment—rapidly test, iterate, and scale.
· Shape long-term innovation strategy, influence the global product pipeline, and strengthen market leadership.
· Partner closely with clinical and commercial teams to ensure real-world impact and patient benefit.
Why HTI?
· A high-visibility, high-impact role inside a global healthcare leader.
· Real autonomy to experiment and pursue breakthrough ideas with resources to scale.
· Direct influence on products that will improve patient lives around the world.
· Collaborative culture that values scientific rigor, creativity, and courageous thinking.
Relocation assistance is available for exceptional candidates.
Strategic Innovation & Vision Setting: Develop and communicate a compelling innovation roadmap for catheter technologies, aligning with the incubator’s mission to deliver transformative solutions. Identify emerging scientific trends, disruptive technologies, and market opportunities to inform long-term strategic goals.
Technology Incubation & Project Leadership: Lead the ideation, conceptualization, and early-stage development of novel catheter designs, including integrating advanced materials, miniaturization techniques, and electromagnetic navigation concepts. Drive projects from proof-of-concept through prototype development, ensuring alignment with clinical needs and regulatory pathways.
Prototype Development & Validation: Architect and oversee the creation of innovative prototypes, tools, and fixtures for pre-clinical testing and First-in-Human trials. Overseeing design and implement robust validation protocols ensuring that prototypes meet safety and regulatory standards and meet manufacturability criteria.
Cross-Functional Collaboration & Leadership: Act as a central figure in a multidisciplinary team—including R&D, manufacturing, regulatory, and external research partners—to facilitate seamless technology transfer and scale-up. Mentor junior engineers and technicians, fostering a culture of scientific curiosity, experimentation, and continuous improvement.
Knowledge Transfer & Process Optimization: Establish and lead knowledge transfer initiatives from incubation to full development and production, including guiding the later stages of process characterization, risk assessments, and process validation.
Regulatory & Quality Assurance Leadership: Develop and review technical documentation, validation protocols, and design controls to ensure compliance with regulatory requirements and other relevant standards to support First In Human use. Facilitate regulatory submissions and support clinical trial activities by providing technical expertise.
Market & Technology Trend Analysis: Stay at the forefront of electrophysiology and catheter innovation by evaluating emerging trends such as electromagnetically navigated devices, flexible materials, and miniaturized electronics. Translate insights into actionable project goals and prototypes that maintain competitive advantage.
Incubator Culture & Strategic Growth: Foster an entrepreneurial environment within the incubator by encouraging risk-taking, rapid prototyping, and iterative testing. Contribute to strategic planning, partnership development, and external collaborations to accelerate incubation success and technology commercialization.
- Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or a related technical discipline. Master’s or PhD preferred, with a focus on medical device development, materials science, or related fields.
- Minimum of 10+ years in medical device R&D, with extensive experience in early-stage technology incubation, innovative device design, and development. Proven track record of leading complex projects from concept to prototype, initial validation to initial clinical use. Must possess a clear mastery of theoretical and practical fundamentals and experimental engineering techniques. Experience in catheter development a plus.
- Deep expertise in design, miniaturization, and advanced manufacturing techniques. Proficiency in prototyping tools (SolidWorks, AutoCAD), validation methodologies, and process excellence tools. Familiarity with electromagnetically navigated devices, advanced materials and flexible electronics is highly desirable.
- Demonstrated ability to lead cross-functional teams, mentor junior engineers, and manage projects with minimal supervision. Strong entrepreneurial mindset with a focus on disruptive innovation and strategic growth.
- Excellent verbal and written communication skills, with experience presenting to executive leadership, regulatory bodies, and external partners. Proven ability to foster collaborative relationships across internal teams and external research institution.
- An estimate of travel up to 25% may be required both domestic and international
- Experience with electromagnetically navigated devices
- Expertise in design validation, process development, and regulatory compliance
- Strong problem-solving, analytical reasoning, and decision-making skills
- Ability to operate independently within a fast-paced, innovative environment
- Knowledge in manufacturing technologies
- Experience in DTV, DTQ
- Strong English communication skills, written and oral
- Business/financial acumen
Required Skills:
Preferred Skills:
Contract Management, Design Thinking, Fact-Based Decision Making, Feasibility Studies, Financial Competence, Leadership, Lean Supply Chain Management, Mechanical Engineering, Product Development, Project Integration Management, Project Management Methodology (PMM), Science, Technology, Engineering, and Math (STEM) Application, Strategic Supply Chain Management, Tactical Planning, Technical Credibility, Vendor Management
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits