Senior Firmware Test Engineer

At Tactile Medical, we develop at-home therapy devices that help patients manage chronic health conditions. The Senior Firmware Test Engineer applies deep firmware and device software test experience to help ensure regulated medical device products are safe, reliable, and ready for release. This position partners closely with firmware engineers to verify embedded software behavior and connected-device workflows across firmware, mobile, and cloud touchpoints. It strengthens how firmware and device software are tested by shaping practical test approaches, building automated coverage, supporting verification evidence, and helping engineering teams resolve complex issues before they reach patients or customers.

• →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.

• 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, including ownership of complex test areas.
• 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.

• Connected medical device experience involving firmware-controlled devices, diagnostics, provisioning, telemetry, secure updates, manufacturing test, service tools, or post-market support.
• Depth testing connected devices that use wired or wireless communication technologies, such as Bluetooth, Wi-Fi, or device-to-device communication.
• Automated test framework, hardware-in-the-loop, simulator, test fixture, CI/CD, regression test, or lab automation design and maintenance background.
• Mobile/cloud integration testing background across edge-to-cloud workflows, connected-device data flows, cybersecurity testing, secure update behavior, or vulnerability verification.
• Familiarity with SBOM/SOUP concepts, medical device cybersecurity guidance, or FDA 510(k) software documentation support.