
Senior Firmware, Quality Engineer bei Precision Neuroscience
Precision Neuroscience · Santa Clara, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in Santa Clara
Key Responsibilities
- Facilitates and completes design control tasks in collaboration with the Firmware Engineering Team.
- Participate in regular Scrum events such as sprint planning, review, and retrospective.
- Collaborates with software developers, hardware engineers and regulatory affairs to create integration tests for new features.
- Develop, review, and execute test plans, test cases, and test scripts for embedded firmware used in or as medical devices.
- Participate in design reviews, risk assessments, and requirements analysis to ensure testability and compliance.
- Applies and adheres to IEC 62304/FDA guidance in developing firmware integration protocols/reports.
- Use lab equipment (e.g., oscilloscopes, logic analyzers, simulators) to test and debug embedded systems.
- Generates and maintains Quality documentation associated with software/firmware engineering.
- Completes software level-debug of software components/hardware.
- Assists in troubleshooting software problems.
- Documents and communicates test results, and track software bugs and their resolution.
- Safety is at the heart of our ethos at Precision - and it is for you too. Candidates for this role must have a strong background in software testing; you will be helping build infrastructure for automated system verification.
Skills, Knowledge and Expertise
- Bachelor’s degree in Electrical Engineering, Computer Science, Biomedical Engineering, or related field.
- 3+ years of experience in firmware/embedded software testing.
- Experience in medical device development or other regulated industry (FDA, ISO 13485).
- Working knowledge of IEC 62304, ISO 14971, ISO 13485 and FDA and EU guidance and regulations related to medical device software.
- Demonstrated scripting ability in Python
- Familiarity with embedded C/C++, real-time operating systems, and hardware-software integration.
- Proficient with test tools and frameworks (e.g., Python, CUnit, Jenkins, Jira, TestRail).
- Excellent analytical, troubleshooting, and documentation skills.
- Experience with automated testing for embedded systems.
- Knowledge of risk management per ISO 14971.
- Familiarity with cybersecurity and software updates in connected medical devices.