BD · 2 hours ago
Staff Reliability Engineer – R&D Engineering
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$125K/yr - $206K/yr
5+ years expBD is one of the largest global medical technology companies in the world, and they are seeking an experienced Staff Reliability Engineer to join their 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.
Health CareMedical DeviceTechnical Support
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
Lead FMEA/FMECA activities for mechanical, electrical, software, and system-level builds
Collaborate with cross-functional teams to identify, assess, and mitigate reliability risks
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
Investigate field failures and manufacturing defects using structured problem-solving methodologies
Drive corrective and preventive actions to eliminate recurrence and improve product robustness
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
Champion Build for Reliability (DfR) principles and guidelines throughout the organization
Provide reliability expertise during build reviews, risk assessments, and product updates
Qualification
Required
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)
Preferred
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
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
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