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Sr Staff Reliability Engineer

Aviso, LLC

  • Fremont, CA
  • 23 days ago
  • Full-time
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Skills

  • American Society for Quality (ASQ)unmatched
  • Analysis Skillsunmatched
  • Best Practicesunmatched
  • Biomedicineunmatched
  • C++ Programming Languageunmatched
  • Capital Equipmentunmatched
  • Certified Quality Engineer (CQE)unmatched
  • Code of Federal Regulationsunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Ecosystemsunmatched
  • Electricityunmatched
  • Electromechanical Systemsunmatched
  • Electromechanicsunmatched
  • Embedded Softwareunmatched
  • Environmental Healthunmatched
  • FDA Requirementsunmatched
  • Failure Analysisunmatched
  • ISO (International Organization for Standardization)unmatched
  • Industry Standardsunmatched
  • Industry/Trade Analysisunmatched
  • Machine Toolunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Engineeringunmatched
  • Manufacturing Systemsunmatched
  • Mechanical Testingunmatched
  • Medical Equipmentunmatched
  • Mentoringunmatched
  • Problem Solving Skillsunmatched
  • Product Programsunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Product/Service Launchunmatched
  • Python Programming/Scripting Languageunmatched
  • Quality Engineeringunmatched
  • Regulationsunmatched
  • Reliability Analysisunmatched
  • Reliability Engineeringunmatched
  • Reliability Testingunmatched
  • Requirements Managementunmatched
  • Research & Development (R&D)unmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Safety/Work Safetyunmatched
  • Statisticsunmatched
  • Structured Analysisunmatched
  • Systems Engineeringunmatched
  • Systems Reliabilityunmatched
  • Test Automationunmatched
  • Test Designunmatched
  • Test Fixturesunmatched
  • Test Harnessunmatched
  • Test Plan/Scheduleunmatched
  • Test Strategyunmatched
  • Testingunmatched
  • Trend Analysisunmatched
  • Validation Testingunmatched
  • Verification Plansunmatched

Description

Position Overview


An innovative and growing medical technology company is seeking a Reliability Quality Engineer to ensure the product reliability and quality of a complex, next-generation medical device ecosystem. In this permanent, full-time role, you will develop and execute product reliability test plans and verification procedures based on design specifications. You will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable, advanced medical systems are designed, verified, and launched successfully.


What Your Day-to-Day Will Involve


  • Lead System-Level Reliability: Drive reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle.

  • Apply Advanced Methodologies: Utilize reliability engineering tools 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 Requirements: Establish reliability requirements, reliability growth plans, and demonstration strategies for NPI (New Product Introduction) programs and sustaining design changes; devise test protocols and author comprehensive test reports.

  • Execute Testing: Design and execute reliability test protocols for mechanical, electrical, environmental, and software-driven subsystems across system, subsystem, and component levels.

  • Cross-Functional Partnership: Partner with Systems Engineering and R&D to ensure proper linkage between design requirements, risk management, reliability verification, and validation activities.

  • Analyze Field Data: Drive reliability insights through the analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.

  • Collaborate on Robustness: Work alongside R&D, Manufacturing Engineering, Supplier Quality, Regulatory Affairs, and Failure Analysis teams to resolve reliability issues.

  • Build Infrastructure: Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups.

  • Champion Culture: Foster a data-driven reliability culture by mentoring engineers and promoting best practices in reliability engineering and statistical analysis.

  • Maintain Compliance: Ensure alignment with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable regulatory standards.

  • EHS Alignment: Understand and adhere to standard corporate Environmental Health and Safety (EHS) policies.

Qualifications (Required)


  • Education: Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Electrical, or Mechanical).

  • Experience: 5+ years of experience in the medical device industry (or an equivalent regulated industry) demonstrating dedicated reliability expertise.

  • Technical Domain: Strong background working with Capital Equipment, complex electromechanical systems, and embedded software devices.

  • Testing Expertise: Proven experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.

  • Predictive Analysis: Experience performing reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.

  • Software Skills: Ability to maintain automated testing frameworks using Python and C++ to execute tests.

  • Soft Skills: Strong analytical, problem-solving, and statistical analysis skills, with the communication clarity needed to influence cross-functional engineering teams.

Qualifications (Preferred)


  • ASQ CQE (Certified Quality Engineer) or CRE (Certified Reliability Engineer) certification.

  • Basic machine tool and manufacturing experience.


Numbers & Facts

LocationFremont, CA
Job TypeFull-time

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