Job Overview
We are seeking a highly motivated and detail-oriented NPD Quality Engineer to join our Companion Diagnostics (CDx) team. This role will be embedded within a cross-functional core team, collaborating closely with pharmaceutical partners to design, develop, and validate IVD companion diagnostics aligned with targeted drug therapies. The ideal candidate will bring expertise in IVD product development, design control, and regulatory compliance, with a strong understanding of clinical and research workflows.
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.
Qualifications
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).
Experience in companion diagnostics, flow cytometry or clinical assays, preferred.
Proven ability to work in cross-functional teams and manage external partnerships.
Excellent communication, documentation, and problem‑solving skills.
Salary
$124,700.00 – $205,800.00 USD Annual
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.
#J-18808-Ljbffr