Technical Program Manager V

About Ascendion
Ascendion is an AI-native software engineering disruptor helping businesses innovate faster, smarter, and with greater impact. We partner with enterprise clients across North America, the UK, Europe, and APAC to solve complex challenges in data, experience design, software product engineering, and workforce transformation. Powered by expert engineers, thousands of AI agents, and our Engineering to the Power of AI (EngineeringAI) method, we deliver measurable outcomes that build trust, unlock value, and accelerate growth.
Learn more at https://ascendion.com/.
Engineering to the Power of AI™, AAVA™, EngineeringAI, Engineering to Elevate Life™, Enterprise PlatformsAI, Data & InsightsAI, ExperienceAI, GCCAI, OperationsAI, Platform EngineeringAI, ProductAI, and Quality EngineeringAI are trademarks or service marks of Ascendion®. AAVA™ is pending registration. Unauthorized use is strictly prohibited.
Ascendion | Engineering to elevate life
We have a culture built on opportunity, inclusion, and a spirit of partnership. Come, change the world with us:
Build the coolest tech for the world’s leading brands
Solve complex problems - and learn new skills
Experience the power of transforming digital engineering for Fortune 500 clients
Master your craft with leading training programs and hands-on experience
Experience a community of change makers!
Join a culture of high-performing innovators with endless ideas and a passion for tech. Our culture is the fabric of our company, and it is what makes us unique and diverse. The way we share ideas, learning, experiences, successes, and joy allows everyone to be their best at Ascendion.
Job Title:Technical Program Manager V
Minimum Qualifications:
Must have directly supported or led software programs governed by medical device regulation
Preferred Qualifications:
Established new release processes from scratch.
Potential companies where candidates may have previously worked: Apple, Verily/Google, Samsung.
Key Responsibilities:
Manage deliverables to completion for a United States Food and Drug Administration (FDA)-approved Hearing Correction feature, classified as Software as a Medical Device (SaMD), in accordance with the Quality Management System (QMS) software release process end-to-end, including defining release scope, schedules, and milestones.
Maintain a single source of truth for release status, dependencies, risks, and open items across all functions.
Coordinate release activities across Program Management (scope/prioritization), Engineering (build/development), Software Quality Assurance (QA), Bench Verification and Validation (V&V) (test coverage, verification, and validation evidence), Risk Management (hazard analysis, risk-benefit assessment), Design Assurance (design controls, Design History File (DHF) completeness), Regulatory (submission impact and change assessment), Post-Market Support (field readiness and complaint handling), and Cybersecurity (vulnerability management and Software Bill of Materials (SBOM)).
Resolve cross-team dependencies, blockers, and conflicts; escalate decisively when timelines or quality are at risk.
Ensure release activities and documentation comply with the Quality Management System (QMS) and applicable standards, including ISO 13485, IEC 62304, ISO 14971, United States Food and Drug Administration (FDA) premarket and postmarket cybersecurity expectations, and IEC 81001-5-1.
Ensure medical device files, verification and validation records, risk files, and change control records are driven to completion and are audit-ready before release by the responsible functions.
Manage the software change control process, ensuring impact assessments and regulatory change assessments are completed by the responsible functions, including Regulatory and Design Assurance.
Track and communicate release risks, mitigations, and residual risk acceptance with the appropriate approvers.
Provide clear and timely status reporting to leadership and stakeholders.
Drive continuous improvement of the release process, tooling, and metrics, including release approval time, on-time milestone rate, and audit finding closure rate.
Location: Burlingame, CA [5 Days Onsite]
Salary Range: The salary for this position is between $199,600 - $249,600 annually. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance] [dental insurance] [vision insurance] [401(k) retirement plan] [long-term disability insurance] [short-term disability insurance] [5 personal days accrued each calendar year. The Paid time off benefits meet the paid sick and safe time laws that pertains to the City/ State] [10-15 days of paid vacation time] [6 paid holidays and 1 floating holiday per calendar year] [Ascendion Learning Management System]
Want to change the world? Let us know.
Tell us about your experiences, education, and ambitions. Bring your knowledge, unique viewpoint, and creativity to the table. Let’s talk!

Work arrangement
Yes