Director - Software Process Excellence

Director - Software Process Excellence

BD's Software Technology Solutions (STS) division is looking for a dynamic, experienced leader to serve as Director of Software Process Excellence. This role will own the strategic and operational aspects of our software development processes, ensuring our products meet all applicable regulatory, safety, and performance standards while fostering a culture of continuous quality improvement.

Job Summary

As a key member of BD's STS leadership team, you will shape and implement SDLC processes across the enterprise. Your expertise in agile software development methodologies, regulatory compliance, and process excellence will be essential to deliver high-quality SaaS and multi-tenant cloud solutions in the highly regulated healthcare IT landscape.

Responsibilities

Collaborate with cross-functional teams to embed quality and regulatory requirements into the product development lifecycle.

Develop and maintain a comprehensive SDLC process that aligns with BD's strategic goals and regulatory requirements.

Lead continuous improvement of the Quality Management System (QMS) processes in STS in compliance with relevant standards.

Work closely with Regulatory Affairs to define and own industry-specific regulatory guidance and frameworks for software development.

Oversee internal and external audit readiness, ensuring full traceability of documentation and actions.

Ensure compliance with regulatory requirements, industry standards, and BD's quality management system, evaluating and implementing tools and automation to streamline processes.

Lead training, coaching, and development of the QA / RA team and STS teams to support a proactive, risk-based approach to QA and RA.

Serve as the primary point of contact for regulatory bodies, complaint handling, and other quality and regulatory reporting as needed.

Communicate effectively with senior stakeholders to provide clarity on STS QMS and regulatory work progress.

Champion agile software development methodology across STS teams.

Conduct regular process reviews and assessments to identify areas for improvement and implement changes.

Ensure alignment with BD'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 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 (Scrum, Kanban) and frameworks (SAFe).

Strong sense of teamwork and collaboration that empowers a team-first culture and continuous learning.

Focused "results" orientation, able to distinguish efforts from results.

Ability to influence, engage and partner closely with stakeholders across all levels of the business.

Strong communication (written / oral) and presentation skills bridging technical and business audiences.

Personal courage in leadership and decision-making.

Hybrid in San Diego preferred; remote employees should be ready to travel once a month to San Diego.

Why Join Us?

BD is one of the world's largest medical technology companies. We are dedicated to inventing and delivering the next generation of life-saving medical technology. At BD, you'll discover a culture that values learning, growth, and the opportunity to make a tangible difference in patient care.

Salary Range

$179,200.00 – $322,500.00 USD Annual

Location

USA, CA – San Diego, Building A & B

Employment Type

Full-time

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