Q Bio · 3 months ago
Technical Program Manager (Software as a Medical Device)
Redwood City
Full-time
Onsite
Senior Level
$180K/yr - $250K/yr
7+ years expQ Bio is an innovative company focused on developing medical technology solutions. As a Technical Program Manager, you will lead cross-functional teams to deliver medical imaging solutions while ensuring compliance with quality standards and regulatory requirements.
BiotechnologyHealth CareInformation TechnologyMedical
Responsibilities
Coordinate a large, multisite project to prototype and validate Q Bio's proprietary approach to whole body quantitative MRI (qMRI)
Develop and execute comprehensive program plans for medical imaging technology, managing the full lifecycle from concept to FDA 510(k) clearance
Define program scope, system requirements, schedules, and deliverables for cross-functional teams and third-party partners
Lead system design reviews, technical deep dives, and trade-off studies to optimize designs for risk reduction and cost efficiency
Drive the end-to-end product lifecycle, including product roadmap development, features definition, risk mitigation, testing, and submission, all within an ISO 14385 compliant quality system (e.g. IEC 62304)
Facilitate collaboration between Mechanical/Electrical Engineering, Data Science, Software, and Magnetics teams through critical design reviews
Manage system-level releases encompassing hardware, software, AI algorithms, robotic components, firmware, and control systems
Drive program execution and coordinate activities across remote, cross-functional internal team and external consultant teams of ~25-30 professionals involved in a program
Establish a quality-first culture, integrating compliance with FDA and international standards in team workflows and practices
Maintain a program-level risk management process covering regulatory, technical, and operational risks (identification, assessment, mitigation tracking)
Continuously assess product performance and feedback, incorporating findings into iterative development cycles to improve user experience, safety, and compliance outcomes
Qualification
Required
Bachelor's degree in Engineering, Computer Science, or related technical field
7+ years of technical program management experience in a regulated environment
At least 3 years in Software as a Medical Device (SaMD) development
Demonstrated success leading programs for SaMD from concept to post-market monitoring
Strong familiarity with regulatory submissions, risk management, and product validation processes in the medical device and digital health space
Strong understanding of medical imaging technologies, preferably MRI systems
Experience managing cross-functional teams including software, hardware, and data science professionals
Solid understanding of software product lifecycle management and relevant guidelines and standards, including ISO 13485, ISO 14971 and IEC 62304
Excellent leadership skills with proven ability to manage remote technical teams
Strong analytical and problem-solving skills for conducting trade-off studies and risk assessments
Outstanding communication and stakeholder management abilities
Preferred
Master's or equivalent work experience in Healthcare or related fields
Experience with clinical trials and/or real-world evidence collection and how to integrate clinical data into product development
Open to candidates who have made a change in the last few years, such as transitioning from engineering to PM or a similar role
Benefits
Competitive compensation and benefits package
Opportunity to work on cutting-edge medical imaging technology with real-world impact
Collaborative environment with top talent in engineering, data science, and healthcare
Opportunity to help scale a start-up business and to professionally grow in a dynamic learning and development environment
Company
Q Bio
On a mission to build the first Clinical Digital Twin Platform and make it accessible to everyone
51-200 employees
H1B Sponsorship
Q Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$91MKey Investors
Andreessen HorowitzKhosla Ventures
2024-07-18Series Unknown· $27M
2020-02-20Series B· $40M
2018-01-01Series A· $16.5M
Leadership Team
Thomas Witzel
Chief Scientific Officer
Recent News
Google Patent
2025-05-04
Google Patent
2025-05-04
Company data provided by crunchbase