Director - Software Process Excellence

BD (Becton, Dickinson and Company)-posted 2 months ago
$179,200 - $322,500/Yr
Full-time • Senior
San Diego, CA
5,001-10,000 employees
Miscellaneous Manufacturing
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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. 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. We are seeking a dynamic and experienced Director, Software Process Excellence to lead the strategic and operational aspects of our software development processes for Quality Management System (QMS) and regulatory compliance. This individual will ensure our software products meet all applicable regulatory, safety, and performance standards while fostering a culture of continuous quality improvement. As a key member of BD's Software Technology Solutions Division (STS) leadership team, you will play a critical role in shaping and implementing our Software Development Lifecycle (SDLC) process across the enterprise.

  • 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.
  • 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.
  • Lead and continuously improve the Quality Management System (QMS) processes in STS in compliance with relevant standards (e.g., ISO) and applicable software standards.
  • 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.
  • Oversee all internal and external audits, ensuring audit readiness and full traceability of documentation and actions.
  • 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.
  • 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.
  • Serve as the primary point of contact for regulatory bodies and notified bodies, complaint handling, and other quality and regulatory reporting as needed.
  • Contribute to the company's strategic direction by providing quality and regulatory thought leadership.
  • 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.
  • Champion the implementation of agile software development methodologies across the various STS teams.
  • Conduct regular process reviews and assessments to identify areas for improvement and implement changes as needed.
  • 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.
  • 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.
  • 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.
  • Healthcare Industry experience is a plus.
  • 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.
  • Competitive salary range of $179,200.00 - $322,500.00 USD Annual.
  • Flexibility to manage work and personal responsibilities effectively.
  • Continuous feedback, recognition, and empowerment to bring your authentic self to work.
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