Test Engineer

Position Summary The Verification and Validation Test Engineer designs, builds, and validates test methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This Role reports to Quality Management, supporting various project teams in different stages of project maturity from R&D through Production. Key Responsibilities • Medical Device Testing: Execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables. • Test Method Development: Design, develop, validate and execute test methods to inform design decisions and verify system functionality. • Documentation: Author test protocols, data sheets, and final reports. Author/assist manufacturing procedures, machine instructions. • Quality Compliance: Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards. • Data Analysis: Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets. • Communication: Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable. Required Qualifications • Education: Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering • Experience: 1-3 years of engineering experience within the medical device or regulated industry. • Regulations: Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards. • Verification & Validation: Direct experience in planning and/or execution of Verification and Validation for complex electrotechnical devices. • Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools such as Excel and Python, or statistical software like Minitab. • Lab Skills: Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors. Preferred Qualifications • Experience with endoscopic surgical laser systems • Experience supporting Design Verification activities for complex medical systems. • Experience working with mixed hardware and software systems. • Experience preparing technical documentation for regulatory submissions. • Experience using Minitab, Linux, and Python.