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# Technical Program Manager V

- **Company:** Spectraforce
- **Location:** Burlingame, CA, United States (Remote available)
- **Experience:** Expert
- **Contract:** Temporary contract
- **Skills:** Testing (Software), Code Coverage, Cyber Security, Software Engineering, Software Vulnerability Management
- **Published:** September 27, 2026
- **Apply:** http://leoforce.us/Careers/Spectraforce/JobDetails.html?jobid=c47e96cc-73fc-43aa-9193-8d157e077f4f&OrgId=1&UserId=5517

## About the Role

* 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

Must-have - T/PM who has supported SW Delivery for SW as a Medical Device.

Nice-to-haves:

 * Stood up new release processes from scratch
 * Potential Companies where Candidates May Have Formerly Worked: Apple, Verily/Google, Samsung

## Description

Release Program Leadership

 * Manage deliverables to completion for Meta'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.)


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