Senior Principal Mechanical Engineer (HTI) - JJMT Electrophysiology
Johnson & Johnson
18 days ago
On-site
Irvine, CA
Operations
Job Summary:
- Lead early-stage incubation of disruptive catheter innovations via Haifa Tech Incubator (HTI), transforming ideas into prototypes and scalable, clinically relevant devices that redefine electrophysiology care.
Responsibilities:
- Develop and communicate an innovation roadmap for catheter technologies.
- Lead ideation, conceptualization, and early-stage development of novel catheter designs (advanced materials, miniaturization, electromagnetic navigation).
- Architect/oversee prototypes and robust validation protocols for safety, regulatory standards, and manufacturability (pre-clinical and First-in-Human).
- Collaborate with R&D, manufacturing, regulatory, and external research partners; mentor junior engineers/technicians.
- Lead knowledge transfer from incubation through development/production (process characterization, risk assessments, process validation).
- Develop/review technical documentation, validation protocols, and design controls; support regulatory submissions and clinical trials.
- Analyze electrophysiology/catheter trends and translate insights into actionable projects.
- Foster an entrepreneurial, rapid experimentation culture; support partnerships and commercialization.
Qualifications:
Required:
- BS in Mechanical/Biomedical/Electrical Engineering or related; MS/PhD preferred (medical device development/materials focus).
- 10+ years medical device R&D with early-stage incubation; proven concept-to-prototype and validation-to-clinical track record; strong experimental engineering fundamentals (catheter development a plus).
- Deep expertise in design, miniaturization, advanced manufacturing; prototyping tools (SolidWorks/AutoCAD); validation/process excellence tools; electromagnetically navigated devices/advanced materials/flexible electronics desirable.
- Cross-functional leadership/mentoring; excellent communication; travel up to 25%.
Preferred:
- Electromagnetically navigated device experience; design validation/process/regulatory compliance; problem-solving/independent execution; manufacturing tech knowledge; DTV/DTQ; strong English; business/financial acumen.
Required/Preferred Skills (as stated):
- Required: Contract Management.
- Preferred: 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.
Compensation/Benefits (if applicable):
- Anticipated base pay: $122K–$212K; eligible for annual performance bonus.
- Employee benefits may include medical/dental/vision, life insurance, disability, retirement (pension/401(k)), and time off (up to 120 vacation hours, 40 sick hours, and up to 13 holiday days annually).
- Lead early-stage incubation of disruptive catheter innovations via Haifa Tech Incubator (HTI), transforming ideas into prototypes and scalable, clinically relevant devices that redefine electrophysiology care.
Responsibilities:
- Develop and communicate an innovation roadmap for catheter technologies.
- Lead ideation, conceptualization, and early-stage development of novel catheter designs (advanced materials, miniaturization, electromagnetic navigation).
- Architect/oversee prototypes and robust validation protocols for safety, regulatory standards, and manufacturability (pre-clinical and First-in-Human).
- Collaborate with R&D, manufacturing, regulatory, and external research partners; mentor junior engineers/technicians.
- Lead knowledge transfer from incubation through development/production (process characterization, risk assessments, process validation).
- Develop/review technical documentation, validation protocols, and design controls; support regulatory submissions and clinical trials.
- Analyze electrophysiology/catheter trends and translate insights into actionable projects.
- Foster an entrepreneurial, rapid experimentation culture; support partnerships and commercialization.
Qualifications:
Required:
- BS in Mechanical/Biomedical/Electrical Engineering or related; MS/PhD preferred (medical device development/materials focus).
- 10+ years medical device R&D with early-stage incubation; proven concept-to-prototype and validation-to-clinical track record; strong experimental engineering fundamentals (catheter development a plus).
- Deep expertise in design, miniaturization, advanced manufacturing; prototyping tools (SolidWorks/AutoCAD); validation/process excellence tools; electromagnetically navigated devices/advanced materials/flexible electronics desirable.
- Cross-functional leadership/mentoring; excellent communication; travel up to 25%.
Preferred:
- Electromagnetically navigated device experience; design validation/process/regulatory compliance; problem-solving/independent execution; manufacturing tech knowledge; DTV/DTQ; strong English; business/financial acumen.
Required/Preferred Skills (as stated):
- Required: Contract Management.
- Preferred: 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.
Compensation/Benefits (if applicable):
- Anticipated base pay: $122K–$212K; eligible for annual performance bonus.
- Employee benefits may include medical/dental/vision, life insurance, disability, retirement (pension/401(k)), and time off (up to 120 vacation hours, 40 sick hours, and up to 13 holiday days annually).