Technical Program Manager V

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