Project Manager

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:

• 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