Johnson & Johnson · 2 months ago
Principal Mechanical Engineer - JJMT Electrophysiology
Irvine, California, United States of America
Full-time
Onsite
Lead/Staff
8+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to improving health outcomes through advanced medical technologies. The Principal Mechanical Engineer will play a critical role in advancing catheter development, driving projects from concept to prototype, and collaborating with internal and external partners to ensure successful technology transfer and regulatory compliance.
Hospital & Health Care
Responsibilities
Under limited supervision, lead projects from initial concept through prototype development, ensuring alignment with clinical needs and regulatory pathways
Drive technical decisions, manage milestones, and de-risk designs to enable downstream development activities
Architect the creation of innovative prototypes, tools, and fixtures for pre-clinical testing
Design and implement robust validation protocols, ensuring safety, regulatory readiness, and manufacturability criteria
Collaborate with internal and external partners to facilitate efficient technology transfer on assigned workstreams
Support knowledge transfer from incubation to development, including guidance on process characterization, risk assessments, and basic process validation activities
Contribute to the preparation of technical documentation, design controls, and validation records to support regulatory submissions and First-In-Human activities as needed
Stay informed about trends in electrophysiology, electromagnetically navigated devices, flexible materials, and miniaturized electronics
Translate insights into practical project goals and prototype concepts to maintain competitive advantage
Foster an entrepreneurial, collaborative environment with a focus on rapid prototyping, iterative testing, and disciplined execution
Contribute to ongoing process improvements and partnerships to accelerate incubation success and technology progression
Qualification
Required
Minimum of 8+ years in medical device R&D, with experience early prototyping an advantage
Bachelor's degree in Mechanical, Biomedical, Electrical Engineering, or a related technical discipline. Master's preferred, with a focus on medical device development, materials science, or related fields
Demonstrated ability to lead projects from concept to prototype, with initial validation and support for early clinical use
Expertise in miniaturization, and advanced manufacturing techniques. Proficiency in prototyping tools (SolidWorks, AutoCAD); familiarity with validation methodologies and process excellence tools
Ability to work independently and with minimal supervision; capable of mentoring junior engineers. Strong collaboration across multidisciplinary teams and external partners. Ability to translate complex scientific concepts into practical, market-ready solutions and interpret technological trends to inform project goals
Excellent verbal and written communication skills; experienced in presenting to project teams, regulatory bodies, and external partners
An estimate of travel up to 15% may be required both domestic and international
Preferred
Experience with electromagnetically navigated devices considered an advantage
Expertise in design validation, process development
Knowledge of manufacturing technologies
familiarity with DTV/DTQ a plus
Strong problem-solving, analytical reasoning, and decision-making skills
ability to operate effectively in a fast-paced, innovative environment
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Company sponsored employee benefit programs
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