We’re looking for a Consultant Test Engineer to join us on a project basis and take ownership of the full testing and quality control process for our medical device (MCU/FPGA/DSP). This role is critical in ensuring the reliability, compliance, and performance of our product — from development through to market release.
Project Scope:
* Lead full-process quality control of device firmware—from R&D handover, through system-level V&V (Verification & Validation), to mass production release and post-market feedback.
* Drive test documentation as the core deliverable: test plans, case libraries, test standards/processes, defect matrices, go-live checklists, regression reports, etc. — all must be auditable and delivered once with high quality.
* Set up or improve testing systems independently and troubleshoot issues quickly in a fast-paced environment.
* Provide hands-on testing support, feedback, and validation planning using our actual product, including firmware, PC software, analyzer devices, and dry testing tools.
What We’re Looking For:
* Proven experience in testing medical devices or embedded firmware systems (MCU/FPGA/DSP).
* Strong understanding of quality control frameworks, regulatory standards, and V&V methodologies.
* Track record of building testing systems, processes, and tools independently.
* Detail-oriented mindset with a focus on documentation and audit-readiness.
* Ability to work across time zones and collaborate with global teams (US & China).