Job Description

Job Title: QA Engineer (Hardware, Firmware, & Systems)

Description:

Own the quality of Sonicus devices and platform end-to-end: plan and execute verification, drive defects to closure, and, crucially,produce clear, audit-ready documentation that stands up to inspection in regulated environments (e.g., 21 CFR Part 11, ISO 17025 contexts). Youll collaborate closely with firmware and hardware engineers; deep EE skills are a plus but not required .

Company Description:

We are an Internet of Things (IoT) company specializing in remote monitoring applications for the healthcare and life sciences industries. Were located in Indianapolis, IN and this is a fully on-site role. Please note, we will not sponsor a Visa for this position.

What youll do

• Translate requirements into risk-based test strategies, test plans, and traceable test cases (hardware, firmware, and system-level).
• Execute bench testing and system verification; log defects with reproduction steps, evidence, and severity.
• Build and maintain audit-ready QA documentation: protocols (IQ/OQ/PQ where applicable), reports, and release sign-offs
• Design and run regression suites for firmware drops; coordinate HIL/smoke checks for field-critical features (alarms, data logging, DataSync/backfill).
• Partner with Firmware Engineering on root-cause analysis; verify fixes and prevent regressions.
• Support RMA investigations with structured failure analysis and corrective action verification. (Youll be teamed with a firmware engineer for deep device-level debug as needed.)
• Track quality metrics (escape rate, MTTR for defects, test coverage, reliability signals) and present concise readouts to stakeholders.
• Contribute to continuous improvement of QA process, templates, and checklists.

Required Skills:

Bachelors degree (engineering preferred)

3+ years in QA for hardware products, software, or regulated industries

Proven test planning, defect management, and release control in a regulated or quality-sensitive environment.

Excellent technical writing; you enjoy producing precise, legible test evidence and reports.

Strong organizational skills, attention to detail, and a mindset for quality

Willingness to learn, collaborate, and adapt to new technologies

Nice to Have Skills:

Exposure to embedded/IoT stacks (ESP32/STM32, LoRaWAN, Wi-Fi/BLE); hands-on with SWD/JTAG, logic analyzers, or oscilloscopes.

Test automation for devices (e.g., Python-based harnesses, CLI/serial control, pytest).

Experience with GxP/Part 11/ISO-aligned documentation practices.

Job Duties:

Test and validate new firmware builds and hardware revisions

Investigate product returns (RMAs), diagnose root causes, and document findings

Develop and maintain test plans, procedures, and checklists

Collaborate with software and hardware engineers to ensure product reliability and performance

Support product changes by collecting and analyzing relevant information, updating Bill of Materials and schematics as needed while preparing analysis for design review meetings

Provide clear, concise reports on testing outcomes and product quality metrics

Were looking for someone curious, thorough, and eager to support our engineering team in delivering robust, reliable devices to our customers. If this sounds like you, wed love to hear from you.

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