Senior Technical Program Manager

CleerlyHealthcare SaaS

Full-TimeSenior

Salary161000 - 186000 USD per year

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Job Details

5+ years of technical program manager experience
Experience working in a highly regulated medical device environment
Familiarity with ISO 13485, ISO 14971, IEC 62304, AAMI TIR 45 standards and regulations
BS in Engineering preferred or other relevant field
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

Driving Cleerly’s product realization process
Leading the development team from planning through verification and validation
Communicating and coordinating activities across the product, engineering, AI, regulatory, and quality teams
Developing and maintaining SOPs, work instructions, and other process documentation
Leading risk analysis activities in accordance with ISO 14971 and IEC 62304
Tracing requirements to product architecture, system design and verification/validation test cases
Coordinating with AI scientists, engineers, and product managers to develop documentation for regulatory submissions
Running agile ceremonies and orchestrating sprint and project milestones
Ensuring engineers have information, requirements, acceptance criteria, and designs for features
Coordinating with engineering managers and product managers on release planning activities
Leading bug triage and prioritization with the team

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