Beyond Risk Management Jobs in Colorado (NOW HIRING)

About Cleerly
We're Cleerly - a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location.
Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks.
At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description.
While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time.
Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use. The adherence to all applicable regulatory and statutory requirements establishes a clear framework for setting measurable quality objectives. Our commitment to continually improving our products and processes proactively manages risks, ensuring ongoing compliance throughout the entire software lifecycle. Understanding this role's relevance and importance is critical to achieving Cleerly's quality objectives.
About the Opportunity
We're looking for our next Senior Technical Program Manager, an experienced scrum master who knows how to shepherd a product portfolio through the full product realization cycle while navigating competing priorities for a regulated product.
What would I be doing?
You'll be responsible for driving Cleerly's product realization process. You'll help to lead the development team from planning through verification and validation to produce the best possible solution in a compliant, high-quality, and timely manner. You'll have strong experience in risk management and delivering products in a regulated environment, such as software as a medical device (SaMD). On any given day you could be doing any of the following:

• Communicating and coordinating activities across the product, engineering, AI, regulatory, and quality teams
• Developing and maintaining SOPs, work instructions, and other process documentation for the team and ensuring team alignment and compliance
• Leading risk analysis activities in accordance with ISO 14971 and IEC 62304
• Tracing requirements to product architecture, system design and verification/validation test cases for compliance and regulatory needs
• Coordinating with AI scientists, engineers, and product managers to develop documentation to support regulatory submissions
• Running agile ceremonies and orchestrating sprint and project milestones in coordination with Product Management
• Ensuring that engineers have all of the information, requirements, acceptance criteria, and designs they need to implement and deliver new features and functionality effectively and efficiently
• Coordinating with engineering managers and product managers on release planning activities, timelines, and documentation
• Leading bug triage and prioritization with the team

Qualifications

• 5+ years of technical program manager experience, or an equal combination of relevant experience in related disciplines
• Experience working in a highly regulated medical device environment with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45 standards and regulations
• BS in Engineering preferred or other relevant field with prior experience
• Certified scrum master with demonstrated experience facilitating agile processes
• Excellent verbal and written communication skills
• Demonstrated work history maintaining product documentation & versioning within a Quality Management System
• Ability to engage technical and non-technical audiences via strong written, verbal, and visual communication skills
• Proven ability to build relationships, collaborate, and influence internal teams and partners
• Strong analytical and problem solving skills
• Capability to succeed in a fast-paced environment with shifting priorities, and manage projects with competing priorities and timelines

Impress us more

• Previous experience working daily with data scientists, engineers, product managers, regulatory and quality team, and clinicians in a digital health environment
• Previous experience working in a start-up environment with a highly collaborative culture, wearing multiple hats as needed and "pitching in" as necessary

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $161,000 - $186,000
• TTC: $186,000 - $214,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.
Working at Cleerly takes HEART. Discover our Core Values:

• H: Humility- be a servant leader
• E: Excellence- deliver world-changing results
• A: Accountability- do what you say; expect the same from others
• R: Remarkable- inspire & innovate with impact
• T: Teamwork- together we win

Don't meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company.
OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.
For more information see our Privacy Policy (https://cleerlyhealth.com/privacy-policy). All official emails will come from @cleerlyhealth.com email accounts.
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