Johnson & Johnson · 1 day ago
Senior Principal Mechanical Engineer (HTI) - JJMT Electrophysiology
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$122K/yr - $212K/yr
10+ years expJohnson & Johnson is a leader in healthcare innovation, aiming to improve health outcomes through advanced medical solutions. The Senior Principal Mechanical Engineer will drive innovation in catheter technology, leading projects from concept to clinical application while collaborating with cross-functional teams to enhance patient care in electrophysiology.
Hospital & Health Care
Responsibilities
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
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
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
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
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
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
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
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
Qualification
Required
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
Preferred
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase