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. 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) clearanceDefine program scope, system requirements, schedules, and deliverables for cross-functional teams and third-party partnersLead system design reviews, technical deep dives, and trade-off studies to optimize designs for risk reduction and cost efficiencyDrive 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 reviewsManage system-level releases encompassing hardware, software, AI algorithms, robotic components, firmware, and control systemsDrive program execution and coordinate activities across remote, cross-functional internal team and external consultant teams of ~25-30 professionals involved in a programEstablish a quality-first culture, integrating compliance with FDA and international standards in team workflows and practicesMaintain 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 EducationBachelor's degree in Engineering, Computer Science, or related technical field; Master's or equivalent work experience in Healthcare or related fields is preferredExperience: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 USStrong familiarity with regulatory submissions, risk management, and product validation processes in the medical device and digital health spaceStrong understanding of medical imaging technologies, preferably MRI systemsExperience managing cross-functional teams including software, hardware, and data science professionalsSolid 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 developmentExcellent leadership skills with proven ability to manage remote technical teamsStrong analytical and problem-solving skills for conducting trade-off studies and risk assessmentsOutstanding communication and stakeholder management abilities What We Offer Opportunity to work on cutting-edge medical imaging technology with real-world impactCollaborative environment with top talent in engineering, data science, and healthcareCompetitive compensation and benefits packageOpportunity to help scale a start-up business and to professionally grow in a dynamic learning and development environment

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