Embedded System Engineer
Futran Solutions
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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