Senior Principal Mechanical Engineer (HTI) - JJMT Electrophysiology

Role Summary

The Senior Principal Engineer role within the Haifa Tech Incubator (HTI) leads early-stage catheter innovation, transforming ideas into prototypes and scalable devices that advance electrophysiology care. The position drives technology incubation, cross-functional collaboration, and regulatory-ready product development to improve patient outcomes and expand market leadership. Based in Irvine, California, on-site 5 days a week.

Responsibilities

• Strategic Innovation & Vision Setting: Develop and communicate an innovation roadmap for catheter technologies aligned with the incubator‚Äôs mission; identify trends and opportunities to inform long-term goals.
• Technology Incubation & Project Leadership: Lead ideation, conceptualization, and early-stage development of novel catheter designs; drive projects from concept to prototype with clinical and regulatory alignment.
• Prototype Development & Validation: Architect and oversee prototypes, tools, and fixtures for pre-clinical testing and First-in-Human trials; implement validation protocols meeting safety, regulatory, and manufacturability criteria.
• Cross-Functional Collaboration & Leadership: Lead a multidisciplinary team to facilitate technology transfer and scale-up; mentor junior engineers and technicians.
• Knowledge Transfer & Process Optimization: Lead knowledge transfer from incubation to production; guide process characterization, risk assessments, and process validation.
• Regulatory & Quality Assurance Leadership: Develop and review technical documentation, validation protocols, and design controls for regulatory compliance; support submissions and clinical activities.
• Market & Technology Trend Analysis: Evaluate trends in electrophysiology and catheter innovation; translate insights into actionable project goals.
• Incubator Culture & Strategic Growth: Foster entrepreneurial environment; contribute to strategic planning and external collaborations to accelerate commercialization.

Qualifications

• Required:
  • Bachelor‚Äôs degree in Mechanical, Biomedical, Electrical Engineering, or related field. Master‚Äôs or PhD preferred (medical device development, materials science, or related).
  • Minimum 10+ years in medical device R&D with experience in early-stage incubation, innovative device design, and development; track record of leading projects from concept to prototype and initial clinical use; catheter development a plus.
  • Deep expertise in design, miniaturization, and advanced manufacturing; proficiency with SolidWorks/AutoCAD; familiarity with electromagnetically navigated devices, advanced materials, and flexible electronics.
  • Proven ability to lead cross-functional teams, mentor juniors, and manage projects with minimal supervision; entrepreneurial mindset focused on disruptive innovation and strategic growth.
  • Excellent verbal and written communication; experience presenting to executives, regulatory bodies, and external partners; ability to foster collaboration across internal teams and external research institutions.
  • Travel up to 25% (domestic and international) may be required.
• 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 in a fast-paced, innovative environment
  • Knowledge in manufacturing technologies
  • Experience in DTV, DTQ
  • Strong English communication skills (written and oral)
  • Business/financial acumen

Skills

• Contract Management
• Design Thinking
• Fact-Based Decision Making
• Feasibility Studies
• Financial Competence
• Leadership
• Lean Supply Chain Management
• Mechanical Engineering
• Product Development
• Project Integration Management
• Project Management Methodology (PMM)
• STEM Application
• Strategic Supply Chain Management
• Tactical Planning
• Technical Credibility
• Vendor Management

Education

• Bachelor‚Äôs degree in Mechanical, Biomedical, Electrical Engineering, or related field; Master‚Äôs or PhD preferred.