Description

Own system verification and test method validation for electro-mechanical and mixed hardware/software medical devices.

This role is on-site.

Responsibilities

• Define and analyze system requirements, clinical workflows, and I/O processes using current systems engineering methods.
• Lead cross-functional verification cycles, from requirement understanding through lab execution to report generation.
• Conduct test method validation, failure mode analysis, and safety/EMC testing per IEC 60601-1 standards.
• Execute tests on Linux workstations, troubleshoot test fixtures, and collect consistent objective evidence.
• Document system architecture, design control elements, and verification protocols for QA/RA stakeholders.

Required Skills

• 7+ years of experience in system verification, with at least 3-4 years specifically in medical devices.
• Hands-on experience with remediation programs, including gap analysis and DHF/design compliance remediation.
• Proficiency in QMS and SoPs within a regulated industry environment.
• Strong knowledge of laboratory equipment: DSO, multimeters, logic analyzers, and analog/digital electronics.
• Experience with MATLAB for data analysis and test automation.
• Familiarity with Agile methodologies and Linux operating systems.

Preferred Skills

• Programming proficiency in Python, Java, or C++ for test automation.
• Experience with DC-DC converters, sensor interfaces, and microcontrollers.

Key Skills

Education

Any Gradute