BD · 1 month ago
Staff NPD Quality Engineer
USA CA - San Diego (BDB)
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, seeking a highly motivated and detail-oriented NPD Quality Engineer to join their Companion Diagnostics team. The role involves collaborating with pharmaceutical partners to design, develop, and validate IVD companion diagnostics aligned with targeted drug therapies, ensuring compliance with regulatory standards and leading quality assurance processes.
Health CareMedical DeviceTechnical Support
Responsibilities
Serve as the Quality representative on cross-functional teams for CDx development projects
Collaborate with external and internal partners to define product requirements, intended use, and clinical performance criteria
Ensure compliance with design control processes per FDA 21 CFR Part 820, ISO 13485, and IVDR
Lead risk management activities (ISO 14971), including hazard analysis, FMEA, and risk mitigation strategies
Support verification and validation (V&V) planning and execution, including analytical and clinical performance studies
Review and approve design documentation, including DHF elements, specifications, and test protocols
Lead and coordinate supplier qualification, incoming inspection, and quality oversight of critical components
Drive root cause analysis and CAPA for design-related issues during development and transfer
Support regulatory submissions (e.g., PMA, 510(k), CE marking) with quality documentation and technical input
Contribute to continuous improvement of NPD quality processes and tools
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred)
Minimum 5 years of experience in Quality Engineering within the IVD or medical device industry
Strong knowledge of design control, risk management, and regulatory standards (FDA, ISO, IVDR)
Proven ability to work in cross-functional teams and manage external partnerships
Excellent communication, documentation, and problem-solving skills
Preferred
Experience in companion diagnostics, flow cytometry or clinical assays
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
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
Medical Device Network
2026-01-17
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2026-01-16
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