Job#: 3053591 Job Description: Technical Project/Program Management - Technical Program Manager V
Compensation: $12- - $130 hourly
Location: Remote, California (Remote)
Role Overview
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.
Key Responsibilities
- 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.
Required Qualifications
Experience: Must have directly supported or led software programs governed by medical device regulations. Senior-level candidates are favored.
Preferred Qualifications
- 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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Everforth Apex Benefits Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.
Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.
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