Project Manager – Embedded Systems & Medical Devices

Project Manager Embedded Systems & Medical Devices

Location: San Diego California USA Onsite work only

Any Visa is fine

Fulltime

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:

• Bachelors 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.