Staff Design Quality Engineer
BDSan Diego, California, United States
Posted December 12, 2025
124700 - 205800 USD year
Full Time
About the Company
BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM is our Purpose, and it’s no small feat.
Job Description
The Staff Design Quality Engineer will play a crucial role in ensuring the quality and regulatory compliance of CareFusion 303, Inc.'s medical devices throughout their entire product lifecycle, from design and development through to market release. This position will involve active participation in design control activities, risk management, and fostering a culture of quality within the engineering teams.
Requirements
- Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related field) required
- 5+ years of experience in Design Quality Engineering within the medical device industry
- Demonstrated experience with medical device design controls (21 CFR Part 820.30) and risk management (ISO 14971)
- Strong understanding of ISO 13485 quality management system requirements
- Experience with Design Verification and Validation activities including software, system, and human factors testing
- Experience in requirements decomposition, traceability, and test strategy development
- Understanding of change impact analysis and regression test scoping methods
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
