BD
Job Summary
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 Summary
The Staff Quality Engineer I is accountable for supporting the ongoing maintenance and improvement of product risk files for medical devices. This role is responsible for conducting periodic reviews, assessing the impact of product changes on risk documentation, and ensuring compliance with applicable regulatory requirements. Key Responsibilities
Lead and execute periodic reviews of risk management files to ensure accuracy, completeness, and regulatory compliance. Evaluate and update risk documentation in response to product design changes, manufacturing updates, or post-market feedback. Provide risk management support for new product development, including initial hazard analysis, risk file creation, and integration with design control processes. Collaborate cross-functionally with R&D, Regulatory Affairs, Medical Affairs and Marketing teams to ensure risk files reflect current product status and intended use. Maintain alignment with ISO 14971 risk management principles and ensure documentation meets IVDR/MDR expectations. Support internal and external audits by providing risk file documentation and responding to auditor inquiries. Track and manage risk file updates using document control systems and ensure timely approvals. Participate in risk-related training and continuous improvement initiatives. Required Qualifications
Bachelor’s degree in science, engineering, or other relevant discipline and 8 years relevant experience OR Master's degree in science, engineering, or other relevant discipline and 5 years relevant experience Skills
Extensive knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Experience with risk management tools such as FMEA, Fault Tree Analysis, or Hazard Analysis. Excellent written and verbal communication skills. Detail-oriented with strong organizational and analytical skills. Work Environment
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit
https://bd.com/careers 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. Salary
Salary Range Information: $130,400.00 - $215,200.00 USD Annual
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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 Summary
The Staff Quality Engineer I is accountable for supporting the ongoing maintenance and improvement of product risk files for medical devices. This role is responsible for conducting periodic reviews, assessing the impact of product changes on risk documentation, and ensuring compliance with applicable regulatory requirements. Key Responsibilities
Lead and execute periodic reviews of risk management files to ensure accuracy, completeness, and regulatory compliance. Evaluate and update risk documentation in response to product design changes, manufacturing updates, or post-market feedback. Provide risk management support for new product development, including initial hazard analysis, risk file creation, and integration with design control processes. Collaborate cross-functionally with R&D, Regulatory Affairs, Medical Affairs and Marketing teams to ensure risk files reflect current product status and intended use. Maintain alignment with ISO 14971 risk management principles and ensure documentation meets IVDR/MDR expectations. Support internal and external audits by providing risk file documentation and responding to auditor inquiries. Track and manage risk file updates using document control systems and ensure timely approvals. Participate in risk-related training and continuous improvement initiatives. Required Qualifications
Bachelor’s degree in science, engineering, or other relevant discipline and 8 years relevant experience OR Master's degree in science, engineering, or other relevant discipline and 5 years relevant experience Skills
Extensive knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products. Experience with risk management tools such as FMEA, Fault Tree Analysis, or Hazard Analysis. Excellent written and verbal communication skills. Detail-oriented with strong organizational and analytical skills. Work Environment
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit
https://bd.com/careers 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. Salary
Salary Range Information: $130,400.00 - $215,200.00 USD Annual
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