As a Technical Program Manager at Q Bio, you will lead the development and execution of our innovative medical technology program. You will work cross-functionally with engineering, data science, regulatory, and manufacturing teams to deliver breakthrough medical imaging solutions that meet strict quality and compliance standards while driving our mission forward.
What You Will Do
- 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
What You Will Bring
Education
- Bachelor's degree in Engineering, Computer Science, or related technical field; Master's or equivalent work experience in Healthcare or related fields is preferred
Experience:
- 7+ years of technical program management experience in a regulated environment, with at least 3 years in Software as a Medical Device (SaMD) 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
Skills & Competencies:
- Demonstrated success leading programs for SaMD from concept to post-market monitoring, with particular experience with class II digital health products in US
- 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.
- Experience with clinical trials and/or real-world evidence collection and how to integrate clinical data into product development
- 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
What We Offer
- Opportunity to work on cutting-edge medical imaging technology with real-world impact
- Collaborative environment with top talent in engineering, data science, and healthcare
- Competitive compensation and benefits package
- Opportunity to help scale a start-up business and to professionally grow in a dynamic learning and development environment
$180,000 - $250,000 a yearApply for this job
