NPD Quality Engineer

Join to apply for the Staff NPD Quality Engineer role at BD (Tissuemed Ltd)

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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.

• 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.

• 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 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 offered to a successful candidate is based on experience, education, skills, and actual work location.

Salary ranges may vary for Field-based and Remote roles. $ - $ USD Annual

• Mid-Senior level

• Full-time

• Quality Assurance

• Medical Equipment Manufacturing