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Senior Principal Mechanical Engineer (HTI) - JJMT Electrophysiology

Johnson & Johnson
On-site
Irvine, CA
$122,000 - $212,000 USD yearly
Clinical Research and Development

Role Summary

The Senior Principal Engineer role is pivotal in establishing the Haifa Tech Incubator (HTI) as a leader in disruptive catheter innovations. The Senior Principal Engineer will drive the incubation of early-stage ideas into high-impact, clinically relevant devices that redefine electrophysiology care. The Senior Principal Engineer leadership will accelerate the transfer of breakthrough technologies from concept to clinical application, ultimately improving patient outcomes and expanding market leadership.

Responsibilities

  • 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.

Qualifications

  • 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

Education

  • 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.

Additional Requirements

  • Travel up to 25% may be required domestically and internationally