Aditi Consulting
Aditi Consulting

Technical Program Manager

Bell Gardens, CA, US • Posted 1 day ago • Updated 1 day ago
Contract Corp To Corp
Contract W2
3 Weeks
On-site
$90 - $100/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • TECHNICAL PROGRAM MANAGER
  • TECHNICAL PROJECT MANAGER
  • PROGRAM MANAGER
  • TECHNICAL PROJECT LEAD
  • SOFTWARE PROGRAM MANAGER
  • SOFTWARE AS A MEDICAL DEVICE
  • SAMD
  • SOFTWARE MEDICAL DEVICE
  • MEDICAL DEVICE SOFTWARE
  • MEDICAL SOFTWARE
  • SOFTWARE DELIVERY
  • SOFTWARE RELEASE
  • RELEASE MANAGEMENT
  • RELEASE PROGRAM
  • SOFTWARE DEVELOPMENT LIFECYCLE
  • SDLC
  • FDA
  • FDA REGULATED
  • MEDICAL DEVICE REGULATIONS
  • 21 CFR
  • QMS
  • QUALITY MANAGEMENT SYSTEM
  • ISO 13485
  • IEC 62304
  • ISO 14971
  • IEC 81001-5-1
  • VERIFICATION AND VALIDATION
  • V&V
  • VERIFICATION
  • VALIDATION
  • RISK MANAGEMENT
  • RISK ASSESSMENT
  • HAZARD ANALYSIS
  • RISK-BENEFIT
  • DESIGN CONTROLS
  • DESIGN ASSURANCE
  • DHF
  • DESIGN HISTORY FILE
  • CHANGE CONTROL
  • CHANGE MANAGEMENT
  • REGULATORY CHANGE ASSESSMENT
  • CYBERSECURITY
  • MEDICAL DEVICE CYBERSECURITY
  • SBOM
  • VULNERABILITY MANAGEMENT
  • RELEASE PROCESS
  • RELEASE GOVERNANCE
  • RELEASE FRAMEWORK
  • RELEASE WORKFLOW
  • RELEASE PROCESS IMPLEMENTATION
  • BUILT RELEASE PROCESS
  • STOOD UP RELEASE PROCESS
  • PROCESS FROM SCRATCH
  • APPLE
  • VERILY
  • GOOGLE
  • SAMSUNG
  • MEDTRONIC
  • ABBOTT
  • JOHNSON & JOHNSON
  • J&J
  • PHILIPS
  • GE HEALTHCARE
  • BOSTON SCIENTIFIC
  • RESMED
  • DEXCOM
  • SIEMENS HEALTHINEERS

Summary

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.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions.  Calls may be recorded.

Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to :messages or by contacting . 

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our 
 
#AditiConsulting                              
#26-06023
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10111892
  • Position Id: 26-06023
  • Posted 1 day ago
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