Director - Software Process Excellence

BD-posted 2 months ago
$179,200 - $322,500/Yr
Full-time • Senior
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

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. 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.

  • 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.
  • Lead and continuously improve the Quality Management System (QMS) processes in STS in compliance with relevant standards (e.g., ISO) and applicable software standards.
  • 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.
  • Be accountable for key performance metrics and drive continuous improvement initiatives.
  • 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.
  • Ability to lead execution of 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.
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Software Engineering Director Resume Examples
•
Software Engineering Director Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service