Senior Firmware QA Engineer for Regulated Medical Devices

Tactile Medical; Minneapolis (MN); On-site; USD 94,000 - 131,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Retirement benefits

Employee stock purchase plan

Paid time off

Job summary

Tactile Medical is seeking a Senior Firmware Test Engineer to ensure safety and reliability of at-home therapy devices. You will verify embedded software, coordinate with firmware, mobile, and cloud teams, and shape automated test strategies to cover regulatory requirements.

The role emphasizes designing robust test approaches, creating evidence for releases, and mentoring others to improve test coverage across Bluetooth, Wi-Fi, and connected-device workflows in a regulated medical environment.

Qualifications

• Bachelor’s degree in Computer Engineering, Computer Science, or a related technical discipline.
• 7+ years of experience testing firmware, embedded software, device software, or software-controlled products.
• Design test approaches, develop automated tests or scripts, and improve repeatability across firmware and device test environments.
• Hands-on regulated medical device software verification experience with test protocols, traceability, and release documentation.
• Knowledge of IEC 62304, ISO 14971, design controls, and requirements management for regulated software.

Responsibilities

• Plan and lead risk-based firmware and device software testing for regulated medical device products.
• Develop and maintain automated tests, test tools, scripts, fixtures, and repeatable test environments that improve coverage and execution efficiency.
• Create and maintain verification documentation, including test protocols, test cases, traceability, objective evidence, results summaries, and release-supporting records.
• Support software verification activities in alignment with IEC 62304, ISO 14971, design controls, requirements management, and regulated software documentation practices.
• Collaborate with firmware, mobile, and cloud engineering teams to test Bluetooth and Wi-Fi connectivity across devices.
• Drive defect investigation by reproducing issues, analyzing logs, and communicating test findings to engineering partners.
• Strengthen firmware test practices through reviews, mentoring, automation improvements, and coordination with offshore contributors.

Skills

Firmware testing

Automated testing

Regulated medical device verification

Test design

Traceability

IEC 62304

ISO 14971

Requirements management

Education

Bachelor's degree in Computer Engineering, Computer Science, or a related technical discipline

Tools

Automated test frameworks

Hardware-in-the-loop

CI/CD

Job description

Tactile Medical is seeking a Senior Firmware Test Engineer to ensure safety and reliability of at-home therapy devices. You will verify embedded software, coordinate with firmware, mobile, and cloud teams, and shape automated test strategies to cover regulatory requirements.

The role emphasizes designing robust test approaches, creating evidence for releases, and mentoring others to improve test coverage across Bluetooth, Wi-Fi, and connected-device workflows in a regulated medical environment.