Job Description
Job DescriptionPosition 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: Bachelors or Masters 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.