Technical Program Manager

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). Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided.

Payrate: $90.00 - $100.00/hr.
 
Responsibilities:

• 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)

 
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

 
Pay Transparency: The typical base pay for this role across the U.S. is: $90.00 - $100.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
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