What are the responsibilities and job description for the Reliability Engineer (Hardware) position at People Force Consulting Inc?
Reliability Engineer (Hardware)
Location: San Jose, CA
Experience : 6 Years
Role: 5 Days Onsite
Job Description :
- As a Staff Reliability Quality Engineer to ensure product reliability and quality within a complex medical device product through the development and execution of product reliability test plan by way of verification procedure based upon product and design specifications.
- This role will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable robotic medical systems are designed, verified, and launched successfully.
What Your Day-To-Day Will Involve:
- Lead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle
- Apply advanced reliability engineering tools and methodologies such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, Accelerated Life Testing (ALT), HALT/HASS, and structured root cause analysis to drive data-based design decisions
- Define reliability requirements, reliability growth plans, and reliability demonstration strategies for NPI programs and sustaining design changes ; devise test protocols and write test reports
- Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.
- Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.
- Drive reliability insights through analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.
- Collaborate cross-functionally with R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues and improve product robustness
- Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups
- Champion a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis
- Ensure compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards
- Understand and adhere to the CLIENT'S BioRobotics EHS policy
The Qualifications We Need You to Possess:
- Bachelor's or Master's degree in engineering (e.g. Biomedical/Electrical/Mechanical)
- 5 years of experience working in medical device or equivalent regulated industry demonstrative of Reliability expertise.
- Background in Capital Equipment and/or complex electromechanical and embedded software devices.
- Experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.
- Perform reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.
- Maintain automated testing frameworks using Python and C to perform testing.
- Strong analytical, problem-solving, statistical analysis and communication skills with the ability to influence cross-functional engineering teams.
The Qualifications We Would Like You to Possess
- ASQ CQE, or CRE certification preferred
- Basic machine tool and manufacturing experience a plus
- Experience with medical device testing or development a plus