Senior Firmware Test Engineer – Regulated Medical Device QA

tactilemedical

Minneapolis (MN)

On-site

USD 94,000 - 131,000

Full time

14 days+
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
PTO
Parental leave
Family medical leave
Stock purchase plan
Life insurance
Disability coverage
Volunteer time off

Job summary

Tactile Medical is seeking a Senior Firmware Test Engineer to help ensure safe, reliable, and release-ready regulated medical device products. You will verify embedded software behavior and connected-device workflows across firmware, mobile, and cloud touchpoints.

Join a team that designs at-home therapy devices and partners with firmware engineers to build automated coverage, document verification evidence, and resolve issues before they reach patients.

Qualifications

  • Bachelor's degree in Computer Engineering, Computer Science, or a related technical discipline.
  • 7+ years of progressive experience testing firmware, embedded software, device software, or software-controlled products.
  • Strong ability to design test approaches, develop automated tests or scripts, analyze test results, and improve repeatability across firmware and device test environments.
  • Hands-on regulated medical device software verification experience, including creation or review of test protocols, test cases, traceability, objective evidence, and release documentation.
  • Working knowledge of IEC 62304, ISO 14971, design controls, requirements management, software verification, and regulated product development documentation.

Responsibilities

  • Plan and lead execution of 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, consistency, and execution efficiency.
  • Create and maintain clear 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 using mobile devices, including provisioning, connection reliability, data exchange, and connected device workflows.
  • Drive defect investigation by reproducing issues, analyzing logs and device behavior, supporting root cause analysis, and communicating test findings to engineering partners.
  • Strengthen firmware test practices through test reviews, mentoring, automation improvements, documentation discipline, and coordination with internal and offshore contributors.

Skills

Firmware testing
Embedded software
Test automation
Regulated software

Education

Bachelor's degree in Computer Engineering/CS

Tools

CI/CD
HIL
Test framework

Job description

Tactile Medical is seeking a Senior Firmware Test Engineer to help ensure safe, reliable, and release-ready regulated medical device products. You will verify embedded software behavior and connected-device workflows across firmware, mobile, and cloud touchpoints.

Join a team that designs at-home therapy devices and partners with firmware engineers to build automated coverage, document verification evidence, and resolve issues before they reach patients.

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