Technical Program Manager V

Technical Program Manager V – SaMD Release Lead

Location: Remote (US Only) or Burlingame, CA

Employment Type: Contract (2 Months initial, with expected 6-month extension and potential for full-time conversion)

Pay Rate: $109 to $139/hour on W2

Benefits: Medical, Dental, Vision, PTO & Sick Leave

Role Overview

We are seeking aSenior Technical Program Manager (TPM V) to lead the end-to-end release lifecycle for FDA-approved Hearing Correction feature—a cutting-edgeSoftware as a Medical Device (SaMD) application.

In this role, you will sit at the intersection of innovative consumer hardware, clinical software, and regulatory compliance. You will serve as the primary operational engine driving release scope, alignment across cross-functional engineering and regulatory teams, and compliance under our Quality Management System (QMS).

Key Responsibilities

1. Release Program Leadership

• Lead end-to-end deliverables for the FDA-approved Hearing Correction SaMD feature in full alignment with the QMS software release process.

• Establish and execute clear release schedules, milestones, dependencies, and critical-path tracking.

• Serve as the single source of truth for release status, risk matrix, blockers, and open items across all functional disciplines.

2. Cross-Functional Coordination & Alignment

• Drive syncs and maintain operational momentum across key stakeholders:

  • Product Management: Scope definition, feature prioritization, and roadmapping.

  • Software Engineering & QA: Build development, test execution, and code readiness.

  • Bench V&V: Test coverage, verification, and validation evidence compilation.

  • Risk Management & Design Assurance: Hazard analyses, risk-benefit assessments, design controls, and Design History File (DHF) completeness.

  • Regulatory & Post-Market Support: Submission impact assessments, field readiness, and complaint-handling workflows.

  • Cybersecurity: Vulnerability management, Software Bill of Materials (SBOM), and security reviews.

• Resolve inter-team dependencies, unblock engineering bottlenecks, and decisively escalate risks impacting timelines or regulatory quality.

3. QMS & Regulatory Compliance

• Ensure all release activities and documentation strictly adhere to internal QMS and relevant industry standards, includingISO 13485, IEC 62304, ISO 14971, FDA pre/post-market cybersecurity expectations, andIEC 81001-5-1.

• Drive Medical Device Files, V&V records, risk files, and change control records to 100% audit readiness prior to release.

• Oversee the software change control pipeline, ensuring thorough impact and regulatory change assessments are executed by Regulatory and Design Assurance owners.

4. Risk Management & Executive Communication

• Identify, track, and communicate release risks, mitigation strategies, and residual risk acceptances to executive leadership and key sign-offs.

• Deliver concise, transparent status reporting to leadership and stakeholders.

• Champion continuous process improvement across release tooling and program metrics (e.g., release-approval cycle time, on-time milestone delivery, audit finding resolution rates).

Qualifications & Experience

• SaMD Regulatory Background: Direct experience leading or supporting software programs governed by medical device regulations (FDA/ISO context).

• Seniority & Track Record: While candidates with strong SaMD domain expertise across varying experience levels will be considered, senior candidates with a proven history of shipping regulated medical software products are highly preferred.

• Standards Expertise: In-depth familiarity with ISO 13485, IEC 62304, ISO 14971, DHF maintenance, and FDA medical device cybersecurity guidance.

• Execution & Influence: Exceptional cross-functional leadership skills with a track record of driving clarity, accountability, and rigor across distributed engineering and clinical/regulatory teams.