Job Description

Role Overview: Direct Hire

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.

🚨 Critical Requirements (Must-Haves)

\> 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.

## What Your Day-to-Day Will Involve

• 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.

## Qualifications

Required:

• 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.

Preferred (Nice-to-Haves):

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

• Basic machine tool and manufacturing experience.