This role is responsible for shaping and managing test infrastructure for medical device development, from concept through manufacturing. You will define and implement test strategies for both in-house and production environments, with a focus on advancing toward fully automated systems. Your work will ensure that hardware and embedded software meet strict performance, reliability, and regulatory requirements.
Key Responsibilities
- Lead the creation and deployment of test setups for PCB and final product validation, including functional and in-circuit testing
- Develop comprehensive test plans and test cases to verify new designs and refine existing products
- Collaborate in design reviews to integrate testability into hardware and firmware early in development
- Design and maintain embedded software for medical devices using C and C++
- Support tools and workflows for embedded development, including version control and build systems
- Conduct code reviews for firmware and test automation software to ensure quality and consistency
- Improve the efficiency, robustness, and scalability of embedded systems through analysis and refactoring
- Produce documentation required by quality management systems across the product lifecycle
- Work closely with hardware engineers to review schematics, layouts, and test methodologies
- Verify hardware testing approaches align with ISO 13485 and other regulatory standards
Qualifications
- Engineering or technical degree with hands-on experience in embedded systems
- Proven background in embedded software development using C and C++
- Familiarity with PCB design tools such as Altium, Eagle, KiCad, or Allegro
- Experience reading schematics and working with lab equipment including oscilloscopes, multimeters, spectrum analyzers, and VNAs
- Proficiency in Python for test automation and scripting
- Strong debugging skills for both hardware and firmware issues
- Experience with quality management systems, particularly ISO 9001 or ISO 13485, is preferred
- Prior experience designing and deploying hardware test processes over 5+ years is a strong asset
