Senior Principal Mechanical Engineer; HTI - JJMT Electrophysiology

Sr. Principal Mechanical Engineer – Irvine, California

Johnson & Johnson – Innovative Medicine & Med Tech.

Based in Irvine, California.

The Senior Principal Engineer will establish the Haifa Tech Incubator (HTI) as a leader in disruptive catheter innovations. The role drives the incubation of early‑stage ideas into high‑impact, clinically relevant devices, accelerating the transfer of breakthrough technologies from concept to clinical application and improving patient outcomes worldwide.

• Strategic Innovation & Vision Setting: Develop and communicate a compelling innovation roadmap for catheter technologies, identifying emerging scientific trends, disruptive technologies, and market opportunities.
• Technology Incubation & Project Leadership: Lead ideation, conceptualization, and early‑stage development of novel catheter designs, integrating advanced materials, miniaturization techniques, and electromagnetic navigation concepts.
• Prototype Development & Validation: Architect and oversee the creation of innovative prototypes, tools, and fixtures for pre‑clinical testing and First‑in‑Human trials, ensuring safety, regulatory compliance, and manufacturability.
• Cross‑Functional Collaboration & Leadership: Facilitate seamless technology transfer with R&D, manufacturing, regulatory, and external research partners; mentor junior engineers; and cultivate a culture of scientific curiosity.
• Knowledge Transfer & Process Optimization: Lead initiatives from incubation to full development and production, guiding process characterization, risk assessments, and process validation.
• Regulatory & Quality Assurance Leadership: Develop technical documentation, validation protocols, and design controls; facilitate regulatory submissions and support clinical trial activities.
• Market & Technology Trend Analysis: Evaluate emerging trends such as electromagnetically navigated devices, flexible materials, and miniaturized electronics; translate insights into actionable project goals.
• Incubator Culture & Strategic Growth: Foster an entrepreneurial environment, encourage risk‑taking, rapid prototyping, and iterative testing; contribute to strategic planning and external collaborations.

• Bachelor’s degree in Mechanical, Biomedical, Electrical Engineering, or related discipline;
  Master’s or PhD preferred with focus on medical device development.
• 10+ years in medical device R&D, with extensive experience in early‑stage technology incubation and innovative device design.
• Proven track record of leading complex projects from concept to prototype, validation, and initial clinical use.
• 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 (Solid Works, AutoCAD) and validation methodologies.
• Familiarity with electromagnetically navigated devices, advanced materials, and flexible electronics is highly desirable.
• Ability to lead cross‑functional teams, mentor junior engineers, and manage projects with minimal supervision.
• Strong entrepreneurial mindset with focus on disruptive innovation and strategic growth.
• Excellent verbal and written communication skills; experience presenting to executive leadership, regulatory bodies, and external partners.
• Travel up to 25% may be required domestically and internationally.

• 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 of manufacturing technologies; experience in DTV, DTQ.
• Business/financial acumen; strong English communication skills, written and oral.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. Johnson & Johnson welcomes qualified candidates who are protected veterans and individuals with disabilities.