Johnson & Johnson MedTech · 9 hours ago
Staff Reliability Engineer
Milpitas, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $201K/yr
8+ years expJohnson & Johnson MedTech is focused on healthcare innovation and is seeking a Staff Reliability Engineer for their Vision team. This role involves owning the reliability, safety, and long-term performance of advanced laser-based surgical treatment equipment, requiring deep expertise in reliability engineering and collaboration across various engineering teams.
Hospital & Health Care
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
Qualification
Required
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
Preferred
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
Critical Thinking
Data Savvy
Process Optimization
Product Reliability
Project Management
Software Development Management
Software Reliability Engineering
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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