Project Manager

Job Description - Project Manager - Embedded Systems & Medical Devices Location: San Diego, California, USA - Onsite work onlyNote: 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. 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. Experience interfacing with customers and third-party vendors

Created: 2026-04-02