Job Summary

The Director, Quality Engineering – Software & ProductSecurityis responsible forleading the integrated software quality and product security strategy for the platform. This role serves as a key member of the Quality Engineering and R&D leadership teams, driving excellence in design controls, risk management, verification and validation, secure software development, cybersecurity maturity, and regulatory compliance.
The Director partners closely with R&D, Product Security, Enterprise Security, Regulatory Affairs, Legal, PMO, and business leadership to ensure the delivery ofhighquality, compliant, and secure software-enabled products across the entire product lifecycle.
This leader will build and develop strong engineering teams, lead strategic improvement initiatives, and ensure BD products meet both regulatory expectations and customer needs.

Primary Responsibilities

Leadership & Strategy

• Define and drive the integrated strategy for software quality engineering and product security across innovation, new product development, sustaining engineering, and end-of-support planning.

• Serve as a member of applicable leadership teams, contributing tolong-termplatform strategy, portfolio planning, and resource alignment.

• Build and sustain a culture of quality, security, compliance, agility, and innovation across the development organization.

Quality Engineering Responsibilities

• Lead the development, implementation, and maintenance of robust Quality Engineering programs, including design controls, software verification/validation, risk management, and compliance with global regulatory requirements.

• Oversee software quality engineering deliverables for design reviews, audits, FDA and Notified Body inspections, and regulatory submissions.

• Align software validation and lifecycle processes across BD to ensure consistent and efficient execution.

• Manage quality metrics and present performance trends during management reviews.

• Identifyand drive continuous improvement within the Quality Management System (QMS) to enhance compliance and product quality.

Product Security Responsibilities

• Provide technical and strategic leadership for secure architecture, threat modeling, vulnerability assessments, penetration testing, and incident response activities.

• Lead adoption of enterprise product security frameworks in alignment with global regulations and corporate standards.

• Drive cybersecurity maturity improvements across the platform including automated security testing, secure SDLC practices, andsupplychainsecurity.

• Partner with R&D engineering teams to integrate security requirements and ensure secure product design, development, and risk mitigation over the lifecycle.

Cross-FunctionalCollaboration

• Build strong, collaborative relationships with R&D, Enterprise Security, Regulatory Affairs, Legal, PMO, and business leaders.

• Facilitate decisionmaking, coordinate cross-functional alignment, and support delivery of secure,highqualityproducts.

• Represent BD in customer discussions, regulatory engagements, and external forums related to software quality and product security.

Team Leadership & People Development

• Build, lead, mentor, and develophigh-performingQuality Engineering and Product Security teams.

• Strengthenleadership capabilities in technical execution, program management, communication, andcross-functionalinfluence.

• Ensure teams are staffed, trained, andresourcedto support business priorities and regulatory expectations.

Operational & Business Responsibilities

• Manage resource planning, budgets, and operational efficiency for quality and security program activities.

• Monitor and report key performance indicators related to software quality,cybersecurity,maturity, and lifecycle performance.

• Drive process improvements that enhance quality, reduce risk, andoptimizedevelopment efficiency.

Education & Experience Requirements

• Bachelor’s degree in Engineering, Computer Science, Cybersecurity, or a related technical fieldrequired; advanced technical or business degree preferred.

• 15+ years of experience in software engineering, software quality, cybersecurity, or related disciplines within a regulated (medical device preferred) industry.

• Minimum 5 years of experience leading engineering, quality, or security teams.

• Experience with connected/embedded systems, secure SDLC, incident response, risk management, and global regulatory frameworks for medical devices and cybersecurity.

• Relevant certifications (e.g., CISSP, CISM, GIAC, CQE, CSQE, ASQ)stronglypreferred.

Knowledge & Skills

• Expert knowledge of software development lifecycle (SDLC), verification andvalidationmethodologies, design controls, and risk management.

• Strongexpertisein cybersecurity threats, secure architecture, threat modeling, and security technologies.

• Deep understanding of regulatory standards including ISO 13485, IEC 62304, 21 CFR 820, and global cybersecurity requirements.

• Excellent leadership, communication, and collaboration skills with the ability to influence at all organizational levels.

• Strong analytical,problem solving, anddecision makingabilities in complex technical environments