Senior Technical Project Manager

iRhythm Technologies, Inc. is a leading digital healthcare company focused on cardiac health solutions. They are seeking a Senior Technical Project Manager to drive the delivery of medical device projects, collaborating with various teams to ensure successful project execution and compliance with regulatory standards.

Responsibilities:

• Collaborate closely with product management, engineering, quality and regulatory assurance to understand and distill business priorities to develop project scope for unmet clinical needs and launch new products
• Drives project planning, WBS, estimation, resources, scheduling, timelines, “what-ifs”, risks and re-planning as required
• Create and maintain the technical project release plan as it pertains to design control process
• Primary owner of project plan initiation through post implementation
• Successful project execution and launch with a mix of people skills, project management, technical expertise and cross functional collaboration with CRM, Manufacturing, Marketing, Customer Support, and Clinical Operations
• Act as a scrum master for sprint planning, backlog refinement, stand-ups, and retrospectives
• Lead and drive stand-ups, recurring project meetings to track progress, timelines, project health and risks
• Facilitate and participate in technical discussions within technical engineers and cross-functional teams
• Act as a core team leader to coordinate efforts for business readiness for deployment and product launch
• Own project risk register and hold regular discussions on risk management activities
• If necessary, author project documentation and assist with system testing
• Work closely with QA/RA to ensure activities performed in compliance with Company SOPs/International Regulatory standards
• In conjunction with technical project management team, own health of projects undertaken and drive continuous improvement of processes
• Drive best practices on the team, deal with ambiguity and competing objectives
• Participate in production release/health monitoring activities

Requirements:

• BS degree in Engineering or related technical field required
• 4+ years' experience leading development projects, ideally with a demonstrated record of transferring design changes to manufacturing and taking new products from development to commercialization
• 8+ years of engineering experience in a professional environment, requiring extensive cross-functional collaboration
• Proven ability to influence without authority, enabling coordination and alignment of matrixed resources
• Strong project management skills including budgeting, planning, tracking, organization, attention to detail, managing competing priorities, analytical and critical thinking, and sound engineering fundamentals
• Strong technical abilities, grounded in ethics and sound decision-making processes
• Deep familiarity with highly technical product development teams and design transfer processes with embedded systems - medical device experience is strongly preferred
• Excellent interpersonal skills, enabling strong alignment with internal / external partners and can navigate conflict constructively
• Effective communication and presentation abilities, with demonstrated ability to synthesize information clearly and convey technical concepts to non-technical audiences
• Software/tools: Proficient using Microsoft Office Suite, including Project and Visio. Working knowledge of Atlassian tools (JIRA, confluence) a plus
• Travel up to 10% (team meetings/offsites)
• Master's degree, M.B.A. or P.M.P. certification a strong plus
• Master's in science or technical field is a plus
• Experience in the medical device industry is a plus
• Experience with IEC standards 62304, 14971, 62366
• Experience with Tools desired – Jira, Product roadmap (Aha!), Project portfolio Management, Requirements management (JAMA)
• Proficiency in AWS/Linux/Unix/Windows environment