Test Engineer
Core
Provide design, technical, and operational support to test processes and manufacturing validation for Pad-Pak capacity expansion in a medical device environment.
Role type
Senior IC test engineer (manufacturing validation)
Builds
Test equipment, processes, and supporting documentation (SOPs, work instructions) compliant with GMP
Domain
Medical devices / Biomedical engineering
Required skills
GMP compliance, IQ/OQ/PQ validation, test equipment calibration, capital acquisition, risk assessment, lean manufacturing, analytical problem-solving
Preferred skills
Cross-functional collaboration, training manufacturing teams, presentation skills
Technologies
Test equipment, calibration tools, process validation software
Responsibilities
Support manufacturing process design and validation; Develop and review test process documents and SOPs; Monitor line performance and execute event plans; Assist in evaluating out-of-specification results; Interface with cross-functional teams and vendors; Deliver technical presentations to management and employees.