BD (Tissuemed Ltd) · 1 month ago
Staff NPD Quality Engineer
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. They are seeking a highly motivated and detail-oriented NPD Quality Engineer to join their Companion Diagnostics team, focusing on IVD product development and regulatory compliance.
Health CareHospitalMedicalMedical Device
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
Benefits
A valuable, competitive package of compensation and benefits programs
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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