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Principal Mechanical Engineer - JJMT Electrophysiology

Johnson & Johnson
Full-time
On-site
Irvine, CA
$102,000 - $177,100 USD yearly
Clinical Research and Development

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Role Summary

The Principal Engineer plays a critical role in advancing catheter development within the Haifa Tech Incubator (HTI) by driving projects from concept to prototype, validating designs, and enabling reliable transitioning toward development and early production. This role emphasizes hands-on technical leadership, rapid problem solving, and mentorship of junior engineers, with regular collaboration across internal and external research partners.

Responsibilities

  • Technology & Project Ownership: 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.
  • Prototype Development & Validation: 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.
  • Design and implement robust validation protocols, ensuring safety, regulatory readiness, and manufacturability criteria.
  • Cross-Functional Collaboration: Collaborate with internal and external partners to facilitate efficient technology transfer on assigned workstreams.
  • Knowledge Transfer & Process Support: Support knowledge transfer from incubation to development, including guidance on process characterization, risk assessments, and basic process validation activities.
  • Regulatory & Documentation Support: Contribute to the preparation of technical documentation, design controls, and validation records to support regulatory submissions and First-In-Human activities as needed.
  • Market & Technology Trend Awareness: 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.
  • Incubator Culture & Continuous Improvement: 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.

Qualifications

  • Minimum of 8+ years in medical device R&D, with experience early prototyping an advantage.
  • Bachelorโ€šร„รดs degree in Mechanical, Biomedical, Electrical Engineering, or a related technical discipline. Masterโ€šร„รดs 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
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