BD Mexico
NPD Quality Engineer – Companion Diagnostics
BD Mexico, San Diego, California, United States, 92189
Job Description Summary
Job Description
We are
the makers of possible 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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us. 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. Experience in companion diagnostics, flow cytometry or clinical assays is highly desirable. 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. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. 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. The salary range for this position is $124,700.00 - $205,800.00 USD Annual.
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the makers of possible 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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a
maker of possible
with us. 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. Experience in companion diagnostics, flow cytometry or clinical assays is highly desirable. 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. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. 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. The salary range for this position is $124,700.00 - $205,800.00 USD Annual.
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