Principal SaMD Technical Program Manager
Wolters Kluwer
full-time
Posted on:
Location Type: Hybrid
Location: Waltham • Illinois, Massachusetts, New Jersey, New York • 🇺🇸 United States
Visit company websiteSalary
💰 $145,500 - $203,900 per year
Job Level
Lead
Tech Stack
Cyber SecurityPMP
About the role
- Drive the functional planning, execution, and delivery of SaMD projects, ensuring effective delivery and alignment with relevant regulatory standards and organization SOPs.
- 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.
- 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.
- Lead Project risk mitigation activities, including timeline, resource, and budgetary risks that arise during the device lifecycle to ensure business priorities are met.
- Act as a liaison between engineering, product, regulatory affairs, clinical, and QA teams to resolve dependencies, facilitate strategic decision-making, and drive process improvement.
- Track and communicate key metrics (risk status, milestone progress, documentation completeness, team velocity) to technical and business stakeholders.
- Engage with executive stakeholders to ensure product needs are understood, prioritized, and delivered.
- Research, recommend, and implement new practices and automation opportunities to accelerate delivery and improve compliance.
Requirements
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
project managementSaMDagile practicesdesign controlrisk managementtechnical documentationQMScybersecurityAI/ML compliancelifecycle management
Soft skills
communicationleadershiporganizational skillscross-functional collaborationproblem-solvingdata analysisstrategic decision-makingteam managementprioritizationfacilitation
Certifications
PMPAgile CertificationRegulatory Certifications