QA Engineer

4 weeks ago

Indianapolis IN, United States Sonicu Full time

Job Title: QA Engineer (Hardware, Firmware, & Systems) Description: Own the quality of Sonicu's 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). You'll 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. We're located in Indianapolis, IN and this is a fully on-site role. Please note, we will not sponsor a Visa for this position. What you'll 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. (You'll 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: • Bachelor's 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 We're 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, we'd love to hear from you.

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