Energy Jobline ZR
Technical Program Manager (Software as a Medical Device) in Redwood City
Energy Jobline ZR, Redwood City, California, United States, 94061
Energy Jobline is the largest and fastest growing global Energy Job Board and Energy Hub. We have an audience reach of over 7 million energy professionals, 400,000+ monthly advertised global energy and engineering jobs, and work with the leading energy companies worldwide.
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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
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
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr
We focus on the Oil & Gas, Renewables, Engineering, Power, and Nuclear markets as well as emerging technologies in EV, Battery, and Fusion. We are committed to ensuring that we offer the most exciting career opportunities from around the world for our jobseekers.
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
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
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.
#J-18808-Ljbffr