Software Design Assurance Engineer

Job description

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. Key Responsibilities: Regulatory & Quality Compliance: Ensure compliance with medical device quality system regulations and standards, including, but not limited to: ISO 13485 (Quality Management Systems for Medical Devices) IEC 62304 (Software Lifecycle Processes for Medical Devices) ISO 14971 (Application of Risk Management to Medical Devices) Maintain comprehensive documentation to support audits, inspections, and external regulatory requirements. Partner with Quality Assuranc...