Job Description SummarySummary
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.
Job DescriptionWe are
the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a
maker of possible with us.
SummaryWe 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.
Key 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.
Required Skills/Experience:- 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 Skills/Experience:- 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.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
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Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
Required Skills
Optional Skills
Primary Work LocationUSA CA - San Diego TC Bldg C&D
Additional LocationsWork ShiftAt BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information$124,700.00 - $205,800.00 USD Annual
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