Software Design Assurance Engineer

Becton Dickinson Medical Devices•San Diego, CA

5d•Onsite

About The Position

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.

Requirements

Bachelor's Degree required. Computer Science, Risk Management or Quality Assurance preferred.
3-5 years experience

Responsibilities

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 Assurance, Compliance, and Engineering teams to align processes with secure SDLC and quality management expectations.
Develop, execute, and maintain test plans, test cases, and validation documentation.
Perform functional, regression, integration, and user acceptance testing to ensure software meets requirements.
Implement best practices for defect tracking, resolution, and root‑cause analysis.
Support secure development initiatives by validating implementation of security controls, vulnerability remediation, and secure coding standards.
Collaborate with Cybersecurity teams to ensure threats and vulnerabilities are identified early and mitigated effectively.
Participate in reviews of architecture, design, and code from a quality and security perspective.
Conduct risk assessments associated with software changes and releases.
Ensure controls, mitigations, and traceability are documented and maintained throughout the development lifecycle.
Use defect data and quality metrics to inform risk‑based decision making and continuous improvement.
Work closely with Engineering, Product, IT, Cybersecurity, and Compliance teams to ensure quality is embedded throughout the development process.
Contribute to process improvements that enhance software reliability, documentation quality, and regulatory readiness.