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Embedded System Engineer

Futran Solutions

San Diego · On-site Full-time Yesterday

About the role

Job Description - Project Manager – Embedded Systems & Medical Devices

Location: San Diego, California, USA – Onsite work only

Position Type: Fulltime

Role Overview:

We are seeking an experienced Project Manager to lead a cross-functional medical device development program covering firmware updates, PC software development, hardware qualification, and manufacturing release. The role owns end-to-end delivery while ensuring compliance with design control and quality system requirements.

Key Responsibilities: • Lead and coordinate multiple parallel workstreams: • Bluetooth module replacement for C6 (MCOT) sensor • Firmware updates for C6 (MCOT) and ePatch 2.5 sensors • Development and release of a PC application tool • Mechanical qualification activities for A15 and A17 monitors • Develop and manage integrated project plans, schedules, dependencies, and risks. • Ensure compliance with Design Controls (including SOP-19) as required and quality processes. • Coordinate Verification & Validation (V&V) planning, execution, and documentation. • Act as the primary interface with cross-functional teams (Firmware, Electrical, Mechanical, QA, RA, Manufacturing) and external partners. • Drive release readiness and transition from development to manufacturing. • Provide regular project status reporting and stakeholder communication.

Education & Experience Required: • Bachelor’s degree in Engineering (Electrical, Electronics, Computer Science). • 8–12 years of overall experience, with 5+ years in project or program management for software/firmware or embedded systems projects. • Proven experience managing projects in regulated environments (medical devices, healthcare, or similar). • Hands-on experience working under formal design control processes and quality systems. • Experience coordinating cross-functional and external teams, including QA, RA, Manufacturing, and third-party partners.

Requirements

  • Bachelor’s degree in Engineering (Electrical, Electronics, Computer Science)
  • 8–12 years of overall experience, with 5+ years in project or program management for software/firmware or embedded systems projects
  • Proven experience managing projects in regulated environments (medical devices, healthcare, or similar)
  • Hands-on experience working under formal design control processes and quality systems
  • Experience coordinating cross-functional and external teams, including QA, RA, Manufacturing, and third-party partners

Responsibilities

  • We are seeking an experienced Project Manager to lead a cross-functional medical device development program covering firmware updates, PC software development, hardware qualification, and manufacturing release
  • The role owns end-to-end delivery while ensuring compliance with design control and quality system requirements
  • Lead and coordinate multiple parallel workstreams:
  • Bluetooth module replacement for C6 (MCOT) sensor
  • Firmware updates for C6 (MCOT) and ePatch 2.5 sensors
  • Development and release of a PC application tool
  • Mechanical qualification activities for A15 and A17 monitors
  • Develop and manage integrated project plans, schedules, dependencies, and risks
  • Ensure compliance with Design Controls (including SOP-19) as required and quality processes
  • Coordinate Verification & Validation (V&V) planning, execution, and documentation
  • Act as the primary interface with cross-functional teams (Firmware, Electrical, Mechanical, QA, RA, Manufacturing) and external partners
  • Drive release readiness and transition from development to manufacturing
  • Provide regular project status reporting and stakeholder communication

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