Medical Device Automation Validation Engineer
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Support validation of automated and robotic medical-device assembly equipment in Cambridge, Ontario, with strong regulated-manufacturing and data-integrity knowledge.
This Senior Automation Validation Engineer validates equipment-based processes, computerized systems, and functional testing activities. You will address part traceability, electronic records, database transactions, system data flows, and regulated-industry controls. Medical-device assembly experience is strongly preferred, alongside protocol execution and automation architecture expertise.
Key Responsibilities:
- Verify device assembly processes and equipment-based functional testing
- Assess data-integrity controls against regulated-industry expectations
- Confirm part traceability, records, transactions, and system data flows
- Execute FAT, SAT, IQ, OQ, and Test Method Validation
- Collaborate with suppliers, quality, manufacturing, controls, and stakeholders
Requirements:
- Six years working with industrial automation or assembly equipment
- Experience in regulated manufacturing environments
- Expertise authoring and executing validation protocols
- Knowledge of databases, electronic records, traceability, and data integrity
- Working knowledge of sensors, actuators, controls, vision, and robotics
Apply validation, traceability, data-integrity, and automation expertise to medical-device manufacturing systems onsite in Cambridge.