Test Engineer
Core
Plan, conduct, and document engineering tests for medical device products, prototypes, and components to ensure safety and quality.
Role type
Test Engineer (Medical Devices)
Builds
Safe, high-quality medical device solutions and validated testing methods
Domain
Medical Devices / Drug Delivery
Required skills
test design, validation principles, structured documentation, CAD software, data analysis tools, equipment calibration, gauge R&R, ISO 13485 compliance, ISO 14971 risk management, FDA Quality System requirements, EU MDR regulations
Preferred skills
catheter development experience, manufacturing experience, Swedish language proficiency
Technologies
CAD software, data analysis tools
Responsibilities
Plan, conduct, and document verification, validation, feasibility, and routine engineering tests; Analyze test data and prepare reports with improvement recommendations; Develop and improve test procedures; Support equipment maintenance and calibration; Collaborate with cross-functional teams to troubleshoot testing challenges; Ensure testing compliance with internal procedures and relevant standards
Seniority
Junior to Mid-level, hands-on IC
