Senior Principal Mechanical Engineer; HTI - JJMT Electrophysiology

Sr. Principal Mechanical Engineer

Our J&J Med Tech Electrophysiology Engineering team is currently recruiting for a Sr. Principal Mechanical Engineer. The position is located in Irvine, California. This position will report on-site 5 days a week.

If you are an entrepreneurial innovator technical leader with a proven track record come join the HTI as a Senior Principal Engineer and take ownership of the next generation of catheter technologies that will redefine electrophysiology and cardiac care worldwide.

We are looking for people who have engineered disruptive devices, driven successful prototypes into clinical proof-of-concept, secured patents or led innovation within RnD. If you thrive on high-impact challenges, move fast, and want the freedom to invent at the intersection of science, engineering, and business, this role was built for you.

Your unique talents will help patients on their journey to wellness.

Job 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:

• 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 (Solid Works, 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…