Job Type
Full-time
Description
The Staff Reliability Engineer serves as the technical authority and cross-functional engineering lead for the reliability architecture of advanced, complex electromechanical and fluidic medical device systems. In this role, you will define, execute, and defend the end-to-end reliability program across the complete product lifecycle.
Responsibilities
• Lead cross-functional engineering teams through the medical device design control process (FDA 21 CFR Part 820, ISO 13485), author and maintain critical DHF deliverables including Reliability Plans and Reliability Reports,
• Drive bottom-up component design FMEAs, system-level hazard analyses to map degradation mechanisms and failure modes directly to patient safety and device availability.
• Evaluate and verify operating design margins, electrical/electronic component derating (voltage, current, power, temperature), and mechanical/fluidic load limits under worst-case boundary conditions to eliminate latent failure mechanisms.
• Direct multi-phase life-cycle testing and wear-decay characterization on dynamic and components translate test outputs into baseline Preventive Maintenance (PM) schedules and service intervals.
• Architect and commission automated, multi-station reliability test fixtures, environmental test loops, and data acquisition systems. Manage internal testing operations and external accredited test laboratories to satisfy project milestones.
• Direct Highly Accelerated Life Testing (HALT) and system accelerated thermal aging to uncover electromechanical and structural vulnerabilities.
• Lead engineering reliability activities for clinical trial readiness, execute transportation and distribution de-risking across different shipping configurations.
• Lead formal engineering investigations into complex technical anomalies across hardware, software, fluidic, and sensor subsystems, apply structured problem-solving (8D, Fishbone, 5 Whys, FTA) to implement robust CAPAs and systematically design out legacy failure modes.
• Leverage connected cloud analytics platforms and defect tracking systems to monitor real-time fleet health, alarm trends, and Pareto failure metrics serve as technical reliability authority on cross-functional escalation boards.
Requirements
Required Skills & Abilities
• Expert knowledge and applied experience with medical device regulations and design standards, including FDA QSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601-1 and IEC 62366-1 with proven track record of authoring DHF reliability deliverables for regulatory submissions (e.g., IDE, 510(k))
• In-depth technical expertise in Design for Reliability (DfR), Highly Accelerated Life Testing (HALT), Accelerated Life Testing (ALT), physics-of-failure, stress derating analysis, Weibull reliability modeling, and statistical MTBF demonstration at defined confidence intervals.
• Proficiency with statistical/reliability software (e.g., Minitab, ReliaSoft / Weibull++, JMP.
• Demonstrated leadership in executing Root Cause Analysis across multi-disciplinary engineering domains, proven capability in managing contract engineering resources, specialized test fixture fabricators, external test labs.
Education & Experience
• Bachelor's degree in Biomedical, Mechanical, Electrical, Systems, or Reliability Engineering with a minimum of 8 years of related engineering experience, OR a Master's degree in engineering with a minimum of 6 years of related engineering experience.
• Minimum 5+ years of direct experience in medical device development (Class II or Class III), with demonstrated expertise in complex electromechanical and dynamic fluidic/hydraulic systems
Travel
• Approximately 10% - 15% travel.
Physical Requirements
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.
• Must be able to access all areas of the facility to determine needs
Salary Description
$138,000 - $155,000
