Senior Technical Program Manager

Cleerly • Denver, CO

2d • Remote

About The Position

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

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• stock options
• paid benefits
• employee perks

What This Job Offers

• Job Type: Full-time
• Career Level: Senior