Product Manager M/F - US

Bluecoders; Palo Alto (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Bluecoders is seeking an experienced leader to own both product and program management for medical software and devices in the US. You will turn clinical needs and technical capabilities into clear priorities and drive cross-functional releases across software and hardware.

You will write user stories, manage risk documentation, lead sprint planning, and coordinate with labs, contract engineering, and regulatory teams to bring AI-enabled medical solutions to market.

Qualifications

• 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.

Responsibilities

• 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
• 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

Skills

Product management

Program management

Medical software

Cross-functional collaboration

Technical writing

Jira/Linear/GitHub Issues

Regulatory awareness

Tools

Jira

Linear

GitHub Issues

Project planning tools

Job description

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 devicesTrack record of writing clear requirements that engineers welcomeProven delivery of cross-functional releases on schedule, across software and hardwareStrong written and verbal communicationComfort in technically complex environmentsFluency with Jira, Linear, GitHub Issues, or similar, plus project-planning toolsUS-basedNice to have:Medical device background and regulated-environment experience (design controls, ISO 13485, IEC 62304, FDA/MDR)Experience with a regulatory submission or clinical studyExposure to AI/ML products with a human in the loopGenuine interest in medicine