Job Title: Senior Firmware Test Engineer (Neuromodulation)
Position Overview
We are seeking a highly skilled Firmware Test Engineer to join our R&D team onsite in St. Paul, MN. You will be responsible for ensuring the safety and efficacy of life-changing Class III medical devices. This role focuses on the verification of neuromodulation systems, specifically Deep Brain Stimulation (DBS) and spinal cord stimulation for chronic pain therapy.
Core Responsibilities
Verification Planning & Execution: Author comprehensive Verification Plans and Test Procedures based on behavioral requirements for complex therapy delivery.
Advanced Scripting: Implement and maintain a library of test scripts using Tcl/Tk.
Formal Design Controls: Drive scripts through formal review cycles, meticulously addressing peer comments and ensuring compliance with FDA/ISO standards.
System Integration: Test the new BLE (Bluetooth Low Energy) layer and integrate it with existing TCL libraries for seamless device-to-programmer communication.
Defect Management: Identify, isolate, and document hardware/firmware bugs with detailed reporting and root cause analysis.
Technical Requirements & Skillset
Domain Expertise: Deep understanding of neuromodulation therapies, including the relationship between voltage/current signals and physiological pain relief.
Sensing & Stimulation: Experience testing systems that incorporate both sensing (feedback loops) and stimulation (delivery of therapy).
Connectivity: Proven experience with Telemetry and wireless protocols, specifically the implementation and testing of BLE stacks.
Scripting Language: Expert-level proficiency in Tcl/Tk is non-negotiable for this role.
Regulatory Knowledge: Familiarity with IEC 62304 and the formal documentation required for Class III medical devices.
Qualifications
Location: Ability to work onsite in St Paul, MN.
Education: B.S. in Electrical Engineering, Computer Science, Biomedical Engineering, or a related field.
Experience: 5+ years in firmware testing, preferably within the medical device, aerospace, or defense industries.