Director - Software Process Excellence

Becton Dickinson Medical Devices-posted 12 days ago

Full-time • Director

Hybrid • San Diego, CA

5,001-10,000 employees

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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. Armed with a growth mindset and a desire to want to do more, learn more, impact more, you are in a great position to join STS to help BD advance the world of health in ways you may never have imagined in your career. 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. Your expertise in developing and maintaining agile software development methodologies, ensuring regulatory compliance, and driving process excellence will be essential in delivering high-quality SaaS and multi-tenant cloud solutions that meet the needs of our customers in the highly regulated healthcare IT landscape. This is a critical leadership role in a fast-growing, innovation-driven team focused on delivering transformative healthcare solutions through software.

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 d efine 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 acr oss 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.

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.
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.

Healthcare Industry experience is a plus.

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