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