About this opportunity
Spectraforce Technologies lists this Technical Program Manager V opportunity in raleigh, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Technical Program Manager V
Duration: 2 months (very likely that this will be extended in to 2027 (possibly another 6 months)
Location: Onsite in Burlingame CA / Remote
Medical Device (SaMD) Technical Program Manager
Key Responsibilities:
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.)
Experience : 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
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.