Staff Reliability Engineer – R&D Engineering

Becton Dickinson Medical Devices • San Diego, CA

2d • Onsite

About The Position

We are seeking an experienced Staff Reliability Engineer to join our R&D Engineering team developing FDA Class II intravenous infusion pumps. This role is pivotal in ensuring product reliability, patient safety, and regulatory compliance across the entire product lifecycle—from concept and design through verification, validation, and post-market surveillance. The successful candidate will apply advanced reliability engineering principles to meet stringent FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 requirements, driving excellence in design and performance for life-critical medical devices.

We are looking for an experienced Staff Reliability Engineer to join our R&D Engineering team working on FDA Class II intravenous infusion pumps. This outstanding role plays a key part in ensuring product reliability, patient safety, and regulatory compliance throughout the entire product lifecycle—from concept and build through verification, validation, and post-market surveillance. The successful candidate will apply advanced reliability engineering principles to satisfy strict FDA Quality System Regulations (21 CFR Part 820) and ISO 13485:2016 standards, promoting excellence in development and performance of life-critical medical devices.

Requirements

• Bachelor’s degree or equivalent experience in Mechanical, Electrical, Biomedical, or Systems Engineering (or related STEM field).
• 5+ years of reliability engineering experience in the medical device industry or other Federal Regulated Industry (Automotive, Pharma, Aerospace)
• Demonstrated proficiency in FMEA/FMECA, reliability modeling, and statistical analysis.
• Solid understanding of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2016.
• Proficiency in reliability tools (e.g., ReliaSoft, Weibull analysis, Monte Carlo simulation).

Nice To Haves

• Advanced degree (MS or PhD or equivalent experience) in Engineering or related field.
• LabVIEW experience strongly preferred. Candidates with hands‑on exposure to LabVIEW for test automation, data acquisition, instrumentation control, or process monitoring will be prioritized, as this skill supports efficiency improvements and enhanced audit and controls testing workflows.
• Familiarity with IEC 60601 series, ISO 14971 (Risk Management), and IEC 62304 (Software Lifecycle).
• Experience with Building for Reliability (DfR) principles and accelerated life testing.
• Strong analytical, communication, and cross-functional collaboration skills.
• Certified Reliability Engineer (CRE) certification is a plus.

Responsibilities

• Reliability Planning & Analysis Develop comprehensive reliability plans aligned with product development achievements. Conduct reliability forecasts, modeling, and statistical evaluations using widely accepted tools in the industry.
• Risk Management Lead FMEA/FMECA activities for mechanical, electrical, software, and system-level builds. Collaborate with cross-functional teams to identify, assess, and mitigate reliability risks.
• Testing & Validation Build and complete service life testing, accelerated aging, and environmental stress screening. Analyze test data to predict performance, identify failure modes, and recommend build improvements.
• Root Cause Analysis Investigate field failures and manufacturing defects using structured problem-solving methodologies. Drive corrective and preventive actions to eliminate recurrence and improve product robustness.
• Regulatory Compliance Ensure conformance to FDA QSR (21 CFR Part 820), ISO 13485:2016, and relevant reliability standards. Prepare and maintain documentation for regulatory submissions, audits, and internal quality reviews.
• Continuous Improvement Champion Build for Reliability (DfR) principles and guidelines throughout the organization. Provide reliability expertise during build reviews, risk assessments, and product updates.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level