Senior Firmware Engineer Neuromodulation

Blue Sages; Saint Paul (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Blue Sages in Minnesota is seeking a Senior Firmware Test Engineer to verify safety and efficacy of neuromodulation medical devices. The role focuses on verification planning, test scripting in Tcl/Tk, and ensuring compliance with FDA/ISO standards in an on-site environment.

You will test BLE communication, work with sensing and stimulation concepts, and drive defects to root cause analysis while collaborating with R&D to deliver robust therapy delivery systems.

Qualifications

• Location: onsite in St Paul, MN.
• Education: B.S. in Electrical Engineering, Computer Science, Biomedical Engineering, or related field.
• Experience: 5+ years in firmware testing, preferably in the medical device, aerospace, or defense industries.

Responsibilities

• Verification Planning & Execution: Author Verification Plans and Test Procedures for complex therapy delivery.
• Advanced Scripting: Develop and maintain test scripts using Tcl/Tk.
• Formal Design Controls: Drive scripts through formal review cycles per FDA/ISO standards.
• System Integration: Test BLE layer and integrate with TCL libraries for device-programmer communication.
• Defect Management: Identify, isolate, and document hardware/firmware bugs with root-cause analysis.

Skills

Tcl/Tk

BLE testing

Telemetry

Neuromodulation knowledge

Sensing & stimulation

IEC 62304

Education

B.S. in Electrical Engineering, Computer Science, Biomedical Engineering, or related field

Job description

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 scriptsusing 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.