Staff Reliability Quality Engineer (Medtech)
Мэтч & Сопровод
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Описание вакансии
TL;DR
Staff Reliability Quality Engineer (Medtech): Ensuring product reliability and quality for robotic medical systems through the development and execution of complex reliability test plans with an accent on electromechanical verification and regulatory compliance. Focus on applying advanced reliability tools like Weibull analysis and ALT to drive data-based design decisions and improve product robustness.
Location: San Jose, CA. Must be based in the US
Salary: $155,000 - $181,000 per year
Company
is a medical robotics company specializing in revolutionary treatments for benign prostatic hyperplasia (BPH).
What you will do
- Lead system-level reliability strategy and testing for complex electromechanical medical devices across the design lifecycle.
- Apply advanced reliability engineering tools including Weibull analysis, Fault Tree Analysis, ALT, and HALT/HASS.
- Define reliability requirements, growth plans, and demonstration strategies for NPI programs and sustaining design changes.
- Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems.
- Collaborate cross-functionally with R&D, Manufacturing, and Regulatory teams to resolve reliability issues and mitigate risks.
- Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups.
Requirements
- Bachelor’s or Master’s degree in Biomedical, Electrical, or Mechanical engineering.
- Minimum 6 years of experience in medical device or equivalent regulated industries with demonstrated reliability expertise.
- Experience with Capital Equipment and complex electromechanical or embedded software devices.
- Proficiency in executing ALT, HALT/HASS, and reliability verification strategies.
- Ability to maintain automated testing frameworks using Python and C++.
- Work Authorization: Must be a US Citizen or Permanent Resident.
Nice to have
- ASQ CQE or CRE certification.
- Basic machine tool and manufacturing experience.
- Prior experience with medical device testing or development.
Culture & Benefits
- Comprehensive health and wellness package including full medical coverage.
- 401(k) plan with employer match.
- On-site gym and various wellbeing benefits.
- Focus on work-life blend with flexible or paid time off and paid parental leave.
- Dedicated career growth via an immersive induction program and a specialized management program.
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