Senior Manager, Device Quality Engineering

As the Senior Manager, Device Quality Engineering, you will lead the global strategy for software quality and design excellence. You will be responsible for building and managing a high-performing team that bridges the gap between rapid Agile development and rigorous medical device regulations. Your leadership ensures that our digital health solutions—including Software as a Medical Device (SaMD) and AI/ML-enabled technologies—are safe, secure, compliant, and scalable.

Your core responsibility will be the strategic oversight of the end-to-end design control process within the Software Development Lifecycle (SDLC). You will define the roadmap for compliance, security-by-design, and global regulatory readiness while mentoring the next generation of quality engineering leaders.

Key Responsibilities

Strategic Leadership & Team Management

• Departmental Authority: Serve as the primary leader and organizational authority on global regulatory standards, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, and AAMI TIR45.
• QMS Roadmap: Drive the evolution of the Quality Management System (QMS), establishing the vision for validation frameworks involving AI/ML, Cloud Infrastructure (SaaS), and Cybersecurity (ISO 81001-5-1).
• People Leadership: Recruit, mentor, and develop a team of quality engineers, fostering a culture of "Compliance at Speed" through Agile best practices.
• Release Accountability: Ensure predictable, complete, and high-quality releases by managing resource allocation and departmental throughput.

Design Quality & Risk Governance

• Architectural Oversight: Direct the review of software architecture to ensure the implementation of safety, security-by-design, and privacy-by-design across all product lines.
• Risk Management Governance: Oversee comprehensive risk management activities, ensuring consistency across Hazard Analysis, Fault Tree Analysis (FTA), and FMEAs for software-driven failure modes.
• V&V Strategy: Act as the final authority for Software Verification and Validation (V&V) strategies; ensure protocols and reports meet the highest standards of robust product performance.

Execution & Compliance

• DHF Lifecycle Management: Ensure organizational compliance from concept to commercialization by governing the Design History File (DHF) and design transfer processes.
• Audit Leadership: Lead the organization’s representation during internal and external audits and inspections (e.g., FDA, Notified Body, MDSAP).

Cross-Functional Collaboration

• Regulatory Partnership: Partner with Regulatory Affairs leadership to strategize and approve technical documentation for global submissions, including FDA, PMDA, and EU-MDR.
• Executive Influence: Provide technical guidance and status updates to R&D, Product, and Program Management executives.

Skills Needed

• Leadership Excellence: Proven ability to manage teams, develop talent, and influence cross-functional stakeholders.
• Strategic Thinking: Strong critical thinking skills with the ability to balance long-term quality goals with immediate business needs.
• Adaptability: Ability to lead a department in a fast-paced, adaptive environment.
• Communication: Exceptional communication and documentation skills, with the ability to translate complex technical risks into business impact.

Educational Requirements & Work Experience 

• Education: Bachelor’s degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical field is required; a Master’s degree or MBA is strongly preferred.
• Experience: 12+ years of experience in quality engineering or product development within the medical device industry, including 3-5 years in a formal management or leadership role.
• Certifications (Preferred): ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt.

This position has an estimated base salary of $195,000 - $250,000, bonus, and equity. #LI-IB1; LI-Hybrid