Job Details

Job Description Summary

Join Our Innovative Team at Software Technology Solutions (STS)! Are you ready to be part of a groundbreaking team that is transforming healthcare through cutting-edge technology? Software Technology Solutions (STS) is BD's global software innovation engine, driving smart connectivity and data‑driven insights across devices. Our mission is to make a tangible difference in patients' lives with world‑class technology capabilities.

Why STS?
• Pioneering Projects – Be at the forefront of innovation as we build BD's first enterprise cloud connectivity and data platform, laying the foundation for our smart‑connected care vision.
• Work with Cutting‑Edge Technologies – Leverage state‑of‑the‑art tools to build innovative solutions using AWS, Go, React, and Python. You'll get hands‑on experience with modern tools and frameworks while solving real‑world challenges at scale.
• Central Innovation Team – Be part of a central software team where your ideas can quickly transform into impactful solutions. Enjoy a dynamic and agile environment with cross‑functional collaboration, making a broad, visible impact throughout the organization.
• Passion for Impact – Join a team that is passionate about improving patient care and customer experience through innovative software development and efficient delivery.
• Supportive Leadership – Our servant leaders are dedicated to your growth. Receive continuous feedback, recognition, and empowerment to bring your authentic self to work every day.
• Flexibility & Balance – We understand the importance of work‑life balance. Enjoy the flexibility to manage your work and personal responsibilities effectively.

Job Responsibilities

• Cross‑Functional Collaboration: Collaborate with cross‑functional teams (Engineering, Product Management, Product Security, Legal, Regulatory, Quality Assurance) to embed quality and regulatory requirements into the product development lifecycle (SDLC) from concept through post‑market. Provide strong partnership and collaboration across Business Units.
• Develop and Maintain SDLC: Develop and maintain a comprehensive SDLC process that aligns with BD's strategic goals and regulatory requirements, enabling the release of SaaS, multi‑tenant, cloud‑based products on a frequent and continual basis.
• QMS Continuous Improvement: Lead and continuously improve the Quality Management System (QMS) processes in STS in compliance with relevant standards (e.g., ISO) and applicable software standards.
• Regulatory Guidance and Frameworks: Closely work with Regulatory Affairs team to define and own the development of industry‑specific regulatory guidance and frameworks for software development in a healthcare IT environment.
• Audit Oversight: Oversee all internal and external audits, ensuring audit readiness and full traceability of documentation and actions.
• Compliance and Tools: Ensure compliance with regulatory requirements, industry standards, and BD's quality management system. Evaluate and implement tools and automation to streamline quality and regulatory processes.
• Training and Development: Lead training, coaching, and development of the QA/RA team and the STS teams to support a proactive, risk‑based approach to QA and RA.
• Subject Matter Expert: Serve as the primary point of contact for regulatory bodies and notified bodies, complaint handling, and other quality and regulatory reporting as needed.
• Strategic Vision and Planning: Contribute to the company's strategic direction by providing quality and regulatory thought leadership.
• Stakeholder Management: Establish and maintain strong relationships with key stakeholders, including customers, business partners, and internal teams. Communicate effectively with senior stakeholders to provide clarity on STS QMS and regulatory work and progress. Communicate with FDA to support BDX software and cyber security programs and interact with central digital health and regulatory COE. Performance metrics: Be accountable for key performance metrics and drive continuous improvement initiatives.
• Agile Implementation: Champion the implementation of agile software development methodologies across the various STS teams.
• Process Reviews: Conduct regular process reviews and assessments to identify areas for improvement and implement changes as needed.
• Cultural Fit and Contribution: Ensure alignment with the company's culture and values, contributing positively to the organizational culture.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field (Master's or RAC certification preferred).
• 10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device or SaMD (Software as a Medical Device) industry.
• Demonstrated success with FDA 510(k) and/or De Novo submissions, CE Marking, and global market approvals.
• Strong understanding of risk management, software lifecycle validation, and design controls for medical device software.
• Healthcare Industry experience is a plus.
• Familiarity with Agile methodologies (e.g., Scrum, Kanban) and frameworks (SAFe).
• Strong sense of teamwork and collaboration that empowers a team first culture and continuous learning.
• Focused “results” orientation. Clearly able to distinguish efforts from results.
• Ability to influence, engage and partner closely with various stakeholders across all levels of the business.
• Strong communication (written/oral) and presentation skills that can effectively bridge the gap between technical and business audiences.
• Personal courage in leadership and decision‑making.
• Collects and analyzes data to influence decision making, establish performance targets, and analyze results.
• Combines strategic planning to paint the big picture with tactical execution to ensure business objectives are achieved.
• Ability to lead execution multiple concurrent efforts.
• Hybrid in San Diego preferred. Remote employees should be ready to travel once a month to San Diego.

Salary Range Information

$179,200.00 – $322,500.00 USD Annual

Required Skills

Optional Skills

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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.

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