We are seeking a Staff Reliability Quality Engineer to ensure product reliability and quality for a complex, next-generation medical device. In this role, you will develop and execute product reliability test plans and verification procedures based on strict product and design specifications.
You will partner closely with R&D, Systems Engineering, Manufacturing, and Quality teams to ensure highly reliable robotic medical systems are successfully designed, verified, and launched.
\> Please Note: Candidates must have a proven background in the medical device industry or an equivalent highly regulated environment, alongside specific experience with complex electromechanical capital equipment.
Industry Experience: 5+ years of experience working in the medical device industry (or equivalent highly regulated industry) with a dedicated focus on Reliability expertise.
Regulatory Compliance: Strong working knowledge and compliance experience with ISO 13485 and FDA Quality System Regulations (21 CFR 820).
Technical Domain: Direct background working with Capital Equipment, complex electromechanical systems, and embedded software devices.
Reliability Testing: Proven experience defining and executing Accelerated Life Testing (ALT), HALT/HASS, and reliability verification strategies.
Automation: Ability to maintain automated testing frameworks using Python and C++ to perform testing.
Strategy & Testing: Lead system-level reliability strategy and testing for complex electromechanical medical devices, ensuring robust product performance across the design lifecycle.
Methodology Application: Apply advanced reliability tools such as Weibull analysis, Reliability Modeling, Fault Tree Analysis, ALT, HALT/HASS, and structured root cause analysis to drive data-based design decisions.
Requirements & Documentation: Define reliability requirements, reliability growth plans, and demonstration strategies for NPI programs and sustaining design changes; devise test protocols and write technical test reports.
Cross-Functional Collaboration: Partner with Systems Engineering, R&D, Manufacturing, Supplier Quality, and Failure Analysis teams to ensure proper linkage between design requirements, risk management, and reliability verification.
Data Analysis: Drive reliability insights through the analysis of field data, complaint trends, and nonconformance data to support product improvements and risk mitigation.
Infrastructure: Develop and implement reliability testing infrastructure, including custom fixtures and automated test setups.
Compliance & Culture: Champion a data-driven reliability culture through mentorship, while ensuring absolute adherence to environmental health and safety (EHS) policies and FDA/ISO standards.
Bachelor’s or Master’s degree in Engineering (Biomedical, Electrical, Mechanical, or related field).
5+ years of reliability engineering experience in the medical device sector.
Experience performing reliability prediction analyses using established industry standards (e.g., MIL-HDBK-217, Telcordia, FIDES).
Strong analytical, problem-solving, statistical analysis, and communication skills with the ability to influence cross-functional engineering teams.
ASQ CQE (Certified Quality Engineer) or CRE (Certified Reliability Engineer) certification.
Basic machine tool and manufacturing experience.