Project Manager
Saxon Global Inc
Job Description - Project Manager - Embedded Systems & Medical Devices
Location: San Diego, California, USA - Onsite work only Note: Must have Medical Devices domain only
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:
Location: San Diego, California, USA - Onsite work only Note: Must have Medical Devices domain only
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.
- 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.
- Strong project planning, execution, and risk management skills.
- Experience driving software and firmware development lifecycles .
- Working knowledge of V&V activities, design documentation, and release processes .
- Technical awareness of embedded systems, firmware (ARM/C), PC applications (C/C++/C#), and hardware-software integration.
- Excellent communication and stakeholder management skills.
- Medical device product development and manufacturing release.
- Firmware updates involving Bluetooth modules, battery management, or component obsolescence.
Vacancy posted 23 hours ago
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