35 years of experience in medical device verification and validation within a regulated industry such as healthcare or aerospace.
Direct experience in systems-level verification and validation within the medical device industry, preferably with electro-mechanical devices.
Strong familiarity with medical device industry standards and regulatory frameworks, including FDA submissions (such as 510(k)) and relevant ISO and IEC standards.
Proven experience in writing and executing system-level verification and validation protocols for complex systems.
Ability to review system-level requirements and define or refine sub-system requirements to support robust testing.
Hands-on experience with medical device testing, ensuring compliance with applicable regulations and industry standards.
Experience understanding, creating, and updating engineering drawings and electrical or electronic schematics.
Experience with validation and hardware test activities, including use of common test equipment.
Ability to perform system-level testing and verification in laboratory environments.
Proficiency in using oscilloscopes and other electronic test instruments.
Familiarity with the Windows operating system, including IT troubleshooting, working with Windows event logs, and creating batch files or task automations.
Proficiency with MS Office tools, including Word, PowerPoint, and Excel, for documentation, reporting, and analysis.
Experience working with medical devices, including X-ray or other radiological systems.
Basic to intermediate soldering skills for prototyping, rework, or test setup support.
Ability to interpret and apply usability and human factors considerations in line with relevant standards.
