Staff Reliability Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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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 were 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 thats 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 patients lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at The Staff Reliability Engineer owns the reliability safety and longterm performance of advanced laserbased 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 lifecyclefrom system architecture through field performance.

You will:

• Define systemlevel reliability plans safety requirements and verification strategies.
• Evaluate system architecture and safety mechanisms (shutters interlocks redundant sensors watchdogs and closedloop energy/position control etc)
• Validate alignment robustness and optical performance under vibration thermal cycling and shock.
• Characterize longterm beam quality optical power stability and dosedelivery reliability.
• Perform WCCA (WorstCase Circuit Analysis) component derating and EMC reliability assessments per relevant standards.
• Model longterm 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 realtime control loops and safety systems.
• Develop physicsoffailure 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 physicsoffailure (PoF) analyses and crossfunctional root cause investigations.
• Drive corrective actions design improvements and longterm reliability growth initiatives.

Qualifications

Required:

• BS/MS in Reliability Engineering Optical Engineering Mechanical Engineering Electrical Engineering Systems Engineering Physics or related field.
• 8 years of handson reliability engineering experience for complex electroopticalmechanical 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 crossdisciplinary 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 606011 (Medical Electrical Safety)
  • IEC(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.

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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