Project Manager – Embedded Systems & Medical DevicesLocation: San Diego, California, USA – Onsite work onlyNote: Must have Medical Devices domain onlyRole 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) sensorFirmware updates for C6 (MCOT) and ePatch 2.5 sensorsDevelopment and release of a PC application toolMechanical qualification activities for A15 and A17 monitorsDevelop 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.Required Skills & Competencies: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.Preferred Experience:Medical device product development and manufacturing release.Firmware updates involving Bluetooth modules, battery management, or component obsolescence.