Technical Program Manager

We are seeking a senior Technical Program Manager with relevant Software as a Medical Device (SaMD) experience. This role focuses on managing the software release process for a key medical device feature. The position requires leading cross-functional teams to ensure deliverables are completed in accordance with the Quality Management System (QMS) and regulatory standards., * Manage deliverables for a Software as a Medical Device (SaMD) feature in accordance with the QMS software release process, including defining release scope, schedule, and milestones.

• Maintain a central source for release status, dependencies, risks, and open items across all functions.
• Coordinate release activities across Product Management, Engineering, Software QA, V&V, Risk Management, Design Assurance, Regulatory, Post-Market Support, and Cybersecurity.
• Resolve cross-team dependencies and blockers, escalating when timelines or quality are at risk.
• Ensure release activities and documentation comply with the QMS and applicable standards such as ISO 13485, IEC 62304, ISO 14971, and cybersecurity guidance.
• Ensure medical device files, verification/validation records, risk files, and change control records are completed and audit-ready before release.
• Manage the software change control process, ensuring impact and regulatory-change assessments are completed.
• Track and communicate release risks, mitigations, and residual risk acceptance with appropriate approvers.
• Provide clear, timely status reporting to leadership and stakeholders.
• Drive continuous improvement of the release process, tooling, and metrics.

Experience: Must have directly supported or led software programs governed by medical device regulations. Senior-level candidates are favored., * Experience establishing new release processes from the ground up.

Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

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