Website Tekfortune Inc.
Tekfortune Inc.
Company : Tekfortune Inc.
Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world s leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the future of work. To support the active project demands and skills gaps, our staffing experts can help you find the best job for you.
Role: Project Manager Embedded Systems & Medical Devices
Location: San Diego, California, USA Onsite work only
Duration: Fulltime
Required Skills: MCOT
Job Description:
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.
For more information and other jobs available please contact our recruitment team at (url removed). To view all the jobs available in the USA and Asia please visit our website at (url removed).