Technical Program Manager

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.

• 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

• Bachelor's degree in Engineering, Computer Science, or related technical field; Master's or equivalent work experience in Healthcare or related fields is preferred

• 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

• 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

• 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