Sr. Quality Engineer, Product Development Processes

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. The Sr. Quality Engineer, Product Development Processes is 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 experience This position will typically work on-site (4 days in office) with some travel (anticipated to be