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Principal SaMD Technical Program Manager
5 days ago
The
Principal SaMD Technical Program Manager
plays a pivotal role in driving the development and delivery of Software as a Medical Device (SaMD) products. This position is responsible for enabling engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA, EU MDR, ISO 13485, and IEC They are responsible for creating and managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering practices. This approach empowers teams to innovate rapidly while maintaining audit-ready outputs and supporting the full product lifecycle, including post-market surveillance and ongoing compliance maintenance.
Collaboration and leadership are central to this role. The Principal SaMD TPM acts as a bridge between engineering, product, regulatory affairs, clinical, and quality assurance teams, facilitating strategic decision-making and resolving cross-functional dependencies. They provide oversight to various aspects of the project portfolio, coordinating meetings and project deliverable milestones. They are responsible for tracking and communicating key metrics—such as risk information, documentation completeness, and team velocity—to both technical and business stakeholders. By engaging with executive leadership and managing demand from diverse sources, they ensure that product needs are clearly understood, prioritized, and delivered in alignment with organizational goals.
As a catalyst for continual improvement, the Principal SaMD TPM researches, recommends, and implements new practices and automation opportunities to accelerate delivery and align activities with key business objectives and product initiatives. The role requires hands-on expertise in agile software development, process facilitation (Scrum, Kanban), and adaptive program management. Through a combination of technical acumen, process optimization, and collaborative leadership, they drive the organization's mission to deliver safe, effective, and innovative medical software solutions.
Responsibilities:
- Lead SaMD Development Projects: Drive the functional planning, execution, and delivery of SaMD projects, ensuring effective delivery and alignment with relevant regulatory standards and organization SOPs.
- Project Management: Apply best-practice project management methodologies to ensure adherence to project timelines, requirements, and goals. Create and maintain dashboards, project plans, schedules, charters, and risk registers to monitor progress and performance, resolve operational issues, and minimize any potential delays. Execute multiple projects simultaneously, prioritizing competing initiatives. Organize and lead project team meetings with detailed agendas, documenting key tasks, action items, and decisions.
- Lifecycle Management: Lead SaMD product development initiatives from Project Kickoff to End-of-Life, ensuring all required lifecycle management activities are planned and executed, including new product development, change management, post-market surveillance, and maintenance activities.
- Risk Management: Lead Project risk mitigation activities, including timeline, resource, and budgetary risks that arise during the device lifecycle to ensure business priorities are met. Support device and compliance risk management activities (hazard analysis, risk assessments) throughout the device life cycle
- Cross-Functional Collaboration: Act as a liaison between engineering, product, regulatory affairs, clinical, and QA teams to resolve dependencies, facilitate strategic decision-making, and drive process improvement. Coordinate meetings and project deliverables.
- Metrics and Reporting: Track and communicate key metrics (risk status, milestone progress, documentation completeness, team velocity) to technical and business stakeholders.
- Stakeholder Engagement: Engage with executive stakeholders to ensure product needs are understood, prioritized, and delivered.
- Process Improvement: Research, recommend, and implement new practices and automation opportunities to accelerate delivery and improve compliance.
Qualifications:
- Bachelor's degree in engineering, computer science, or related field (or equivalent practical experience).
- 9+ years of experience working on SaMD or regulated medical software products in technical program management, engineering, or project management roles using agile practices. Knowledge of FDA and EU MDR-related standards.
- Hands-on experience with design control, risk management, and technical documentation (DHF, traceability matrix, protocols, reports, risk assessments, testing, etc.).
- Demonstrated experience working under a formal QMS (ISO 13485, 21 CFR 820)
- Experience working with an eQMS and other tooling for managing SaMD projects.
- Strong understanding of modern agile software development practices and adaptive program management.
- Excellent communication, leadership, and organizational skills; ability to work effectively in a matrixed, cross-functional environment.
- Experience supporting products through the full lifecycle, including post-market activities.
- Ability to analyze data and communicate effectively through written and graphical formats to large audiences, including executives.
- Experience with cybersecurity and/or AI/ML compliance for medical software is a plus.
- Agile, PMP and Regulatory Certifications are a plus.
Our Interview Practices
To maintain a fair and genuine hiring process, we kindly ask that all candidates participate in interviews without the assistance of AI tools or external prompts. Our interview process is designed to assess your individual skills, experiences, and communication style. We value authenticity and want to ensure we're getting to know you—not a digital assistant. To help maintain this integrity, we ask to remove virtual backgrounds and include in-person interviews in our hiring process. Please note that use of AI-generated responses or third-party support during interviews will be grounds for disqualification from the recruitment process.
Applicants may be required to appear onsite at a Wolters Kluwer office as part of the recruitment process.
Compensation:
Target salary range CA, CT, CO, DC, HI, IL, MA, MD, MN, NY, RI, WA: $145,500 - $203,900
