Product Manager M/F - US

Own both what gets built and how it gets delivered (50% product / 50% program)

• Product:
  • Turn clinical needs and technical capabilities into clear priorities and features
  • Define workflows and user experience for AI-assisted use in high-stakes, time-critical settings
  • Write user stories and acceptance criteria; own and prioritize the backlog
  • Document user-related risks and support risk mitigation
  • Run usability evaluations and feed findings into the roadmap
  • Attend clinical cases as the hands-on software operator
• Program:
  • Build and own the integrated plan across software, hardware, AI, clinical, and regulatory workstreams
  • Lead sprint and release planning
  • Drive releases through design controls with Quality and Regulatory
  • Coordinate external partners (labs, contract engineering, manufacturing)
  • Prepare the system for clinical studies
  • Report status, risks, and trade-offs clearly to leadership
• Act as the translator between clinicians, engineers, and AI teams

• Must have:
  • 5+ years in both product and program/project management on medical software or devices
  • Track record of writing clear requirements that engineers welcome
  • Proven delivery of cross-functional releases on schedule, across software and hardware
  • Strong written and verbal communication
  • Comfort in technically complex environments
  • Fluency with Jira, Linear, GitHub Issues, or similar, plus project-planning tools
  • US-based
• Nice to have:
  • Medical device background and regulated-environment experience (design controls, ISO 13485, IEC 62304, FDA/MDR)
  • Experience with a regulatory submission or clinical study
  • Exposure to AI/ML products with a human in the loop
  • Genuine interest in medicine