Sr. Quality Engineer, Product Development Processes

Description We are the makers of possibleBD 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.The Sr. Quality Engineer, Product Development Processesis responsible for coordination, planning, and implementation of product development processes including design control, risk management, and change control. This position will work closely with cross-functional teams to create, implement, and improve total product life cycle business processes for BD MMS products. The position provides opportunity to help define and manage critical processes for all development phases for MMS products (e.g., infusion pumps, infusion sets, medical inventory optimization, medicine dispensing, etc.). This individual will participate in project planning, scheduling, and tracking to support business process improvements, remediation projects and associate training.Responsibilities:Supports Product Development Process Leadership with implementation of key business process improvements and gap assessments.Collaborates with R&D engineering, medical affairs, regulatory, quality systems, product quality and risk management, and other functions as necessary to ensure stakeholder engagement and alignment with business processes including design control, risk management, non-product software validation, and change control processes.Helps to ensure that business processes for design control, risk management, non-product software validation, and change control processes meet regulatory and corporate requirements such as ISO 14971, 13485, 9001 and FDA QMSR. Adheres to project and regulatory timeline expectations.Exhibits technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance).Participates in and assists with facilitation of training for business processes and procedures.Monitors business process metrics and generates monthly reports for leadership review. Complies with company procedures and policies, government regulations.Perform any other tasks as assigned. Required Qualifications:BS in technical field with 5 years or MS in technical field with 3 years of Quality, Risk Management and Design Controls experience within the medical device industry.Strong technical writing experience required.Experience in managing quality improvement projects required.Able to effectively multi-task and work independently with a high level of initiative.Preferred Qualifications:Non-product software validation experience Infusion pump product experienceThis position will typically work on-site (4 days in office) with some travel (anticipated to be 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. 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.

Created: 2026-04-02