Software Design Assurance Engineer
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Overview
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 Assurance, Compliance, and Engineering teams to align processes with secure SDLC and quality management expectations.
Software Testing & Validation
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.
Cybersecurity Integration
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.
ISO/IEC 27001 Information Security Management
FDA Medical Device Cybersecurity Guidance (pre‑ and post‑market)
Risk Management & Governance
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.
Cross‑Functional Collaboration
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.
Minimum Requirement:
Bachelor's Degree required. Computer Science, Risk Management or Quality Assurance preferred.
3-5 years experience
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. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
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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Primary Work Location
USA CA - San Diego Bldg A&BAdditional Locations
Work Shift
At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$102,000.00 - $168,200.00 USD AnnualAutomate your job search with Sonara.
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