Description

Own system verification for electro-mechanical medical devices, from requirement analysis through lab testing and compliance remediation.

This role is on-site.

Responsibilities

• Define and analyze system requirements, clinical workflows, and I/O processes using systems engineering methods.
• Execute full-cycle system verification in the lab, including test setup, fixture troubleshooting, and data collection for mixed hardware/software products.
• Conduct gap analysis and drive remediation for design, documentation, and compliance issues aligned with QMS, FDA, and ISO standards.
• Perform test method validation, failure mode analysis, and risk management to ensure audit readiness and documentation completeness.
• Maintain design traceability and serve as the R&D representative on cross-functional deliverables, mentoring team members and reviewing technical work.

Required Skills

• 2+ full cycles of system verification in medical devices (minimum 3-4 years experience in this specific domain).
• Hands-on experience with lab equipment: DSO, multimeter, logic analyzer.
• Knowledge of analog/digital electronics: DC-DC power supplies, sensor interfaces, microcontrollers.
• Proficiency in communication protocols: CAN, RS485, RS232, Ethernet, USB, I2C, SPI, UART.
• Experience working with Linux workstations for test execution and data analysis.
• Strong understanding of design control elements, DHF remediation, and compliance findings closure.

Preferred Skills

• Programming knowledge in Python, Java, or C++.
• Experience creating test setups and handling troubleshooting for complex electro-mechanical fixtures.

Key Skills

Education

Bachelor's degree