Technical Program Manager
$90 - $100 per hourAditi Consulting
Job Description
Job Description
Payrate: $90.00 - $100.00/hr.
- Release Program Leadership:
- Manage deliverables to completion for Company’s FDA approved Hearing Correction feature - software as medical device (SaMD) in accordance with Quality Management System (QMS) software release process end-to-end: define release scope, schedule, and milestones.
- Maintain a single source of truth for release status, dependencies, risks, and open items across all functions.
- Cross-Functional Coordination:
- Coordinate release activities across PM (scope/prioritization), Engineering (build/development), Software QA, Bench V&V (test coverage, verification, validation evidence), Risk Management (hazard analysis, risk-benefit), Design Assurance (design controls, DHF completeness), Regulatory (submission impact, change assessment), Post-Market Support (field readiness, complaint handling), and Cybersecurity (vulnerability management, SBOM).
- Resolve cross-team dependencies, blockers, and conflicts; escalate decisively when timelines or quality are at risk.
- QMS & Compliance Alignment:
- Ensure release activities and documentation comply with the QMS and applicable standards (e.g., ISO 13485, IEC 62304, ISO 14971, and cybersecurity guidance such as FDA premarket/postmarket cybersecurity expectations and IEC 81001-5-1).
- Ensure medical device file , verification/validation records, risk files, and change control records are driven to completion and audit-ready before release by responsible functions.
- Manage software change control process, ensuring impact and regulatory-change assessments are completed by the responsible functions (Regulatory/Design Assurance).
- Risk, Quality & Communication:
- Track and communicate release risks, mitigations, and residual risk acceptance with the appropriate approvers.
- Provide clear, timely status reporting to leadership and stakeholders.
- Drive continuous improvement of the release process, tooling, and metrics (release-approval time, on-time milestone rate audit findings closure rate etc)
- Must have directly supported or led software programs governed by medical device regulations.
- Not limited to 10 + years of experience as long as candidates have relevant SaMD experience - but more senior candidates are favored
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Vacancy posted 17 days ago
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