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.
Job Responsibilities:
Act as the Quality core team member for sustaining engineering projects.
Participate in design control activities, including design reviews, risk management, and verification and validation planning and execution.
Support the development and maintenance of design and development files (DDFs) to ensure compliance with internal procedures and external regulations (e.g., FDA, ISO 13485).
Perform and/or review risk management activities, including Hazard Analysis, FMEA (Failure Mode and Effects Analysis), and risk-benefit analysis, ensuring appropriate risk mitigation strategies are identified and implemented.
Provide quality engineering support for CAPA activities, including performing investigations and implementation of actions, and executing verification of effectiveness (VOE) to ensure solutions are sustained and compliant with FDA/ISO and internal requirements.
Author field issue assessments using post-market data, complaint investigations, and risk analyses in compliance with 21 CFR 806 and EU MDR.
Participate in internal and external audits (e.g., FDA, Notified Body).
Mentor junior quality engineers and provide technical guidance on design quality principles and practices.
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, Marketing) to ensure quality objectives are met.
Develop and implement quality plans, procedures, and work instructions to enhance the effectiveness of the quality management system.
Contribute to continuous improvement initiatives within the quality organization, identifying opportunities for process optimization.
Job Qualifications:
Minimum Requirements
Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Industrial, or related field)
5–7 years of experience in Design Quality Engineering within the medical device industry
Strong working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485
Hands-on experience with design controls and risk management (ISO 14971)
Basic understanding of corrections/removals processes (21 CFR Part 806)
Strong analytical and problem-solving skills with the ability to investigate complex issues
Effective written and verbal communication skills
Ability to work both independently and collaboratively in a fast-paced environment
Preferred Qualifications
Master’s degree in Engineering
Experience with statistical software (e.g., Minitab, JMP)
ASQ certification (CQE, CRE, CMQ/OE)
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
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.
Required Skills
Optional Skills
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At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under " Our Commitment to You"
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information
$105,500.00 - $168,800.00 USD Annual
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its more than 70,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
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