Staff Reliability Engineer

Johnson & Johnson Innovative Medicine • Milpitas, CA

1d

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com We are searching for the best talent to join our Vision team as a Staff Reliability Engineer, R&D located in Milpitas, California. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Purpose: The Staff Reliability Engineer owns the reliability, safety, and long‑term performance of advanced laser‑based surgical treatment equipment, including ultrafast laser sources, optical delivery subsystems, precision mechatronics, control electronics, and embedded software. This role requires deep expertise in reliability engineering for laser/optics, complex electromechanical systems, and medical device regulatory standards. The engineer will define, lead, and execute the reliability strategy across the entire product lifecycle—from system architecture through field performance.

Requirements

• BS/MS in Reliability Engineering, Optical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, Physics, or related field.
• 8+ years of hands‑on reliability engineering experience for complex electro‑optical‑mechanical systems.
• Practical experience with FMEA, HALT/HASS, accelerated life modeling, and Weibull/statistical reliability analysis.
• Demonstrated ability to developing and executing qualification test plans and interpreting results for both new product development and on-market products.
• Proficiency with reliability analysis and data tools such as Minitab, JMP, Python, MATLAB, etc.
• Proven track record and ability to lead cross‑disciplinary teams to deliver reliability engineering tasks and improve the product quality on schedule.

Nice To Haves

• Reliability engineering certification (ASQ CRE or equivalent).
• Strong knowledge of medical device standards, including: ISO 14971 (Risk Management) IEC 60601‑1 (Medical Electrical Safety) IEC 60601‑1‑2 (EMC) IEC 60825 (Laser Safety) IEC 62304 (Software Lifecycle)
• Experience with surgical or therapeutic laser systems, ultrafast lasers, and optical delivery design.
• Experience with field reliability programs and servicing strategies for regulated devices.

Responsibilities

• Define system‑level reliability plans, safety requirements, and verification strategies.
• Evaluate system architecture and safety mechanisms (shutters, interlocks, redundant sensors, watchdogs, and closed‑loop energy/position control, etc)
• Validate alignment robustness and optical performance under vibration, thermal cycling, and shock.
• Characterize long‑term beam quality, optical power stability, and dose‑delivery reliability.
• Perform WCCA (Worst‑Case Circuit Analysis), component derating, and EMC reliability assessments per relevant standards.
• Model long‑term mechanical degradation such as wear, thermal drift, bearing/flexure fatigue, and mechanical reliability limits.
• Analyze firmware failure modes impacting laser firing logic, sensing, UI behavior, real‑time control loops, and safety systems.
• Develop physics‑of‑failure and accelerated life models across optical, electrical, mechanical, and software subsystems.
• Perform Weibull analyses, lifetime prediction modeling, and reliability growth modeling.
• Create and execute comprehensive qualification plans (e.g., laser aging/lifetime, HALT/HASS, thermal & humidity cycling, vibration & shock, contamination/particulate sensitivity).
• Ensure compliance with ISO 13485 and associated medical device reliability requirements.
• Collaborate with optical, electrical, mechanical, software, manufacturing, quality, and regulatory engineering teams to prioritize and resolve reliability risks.
• Guide internal teams and external partners in reliability engineering best practices and medical device development processes.
• Monitor field metrics such as MTBF, service logs, system usage hours, and calibration/maintenance trends.
• Lead 8D investigations, physics‑of‑failure (PoF) analyses, and cross‑functional root cause investigations.
• Drive corrective actions, design improvements, and long‑term reliability growth initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level