Medical Device Automation Validation Engineer

3 days ago

Cambridge, Region of Waterloo, Canada United Pharma Full-time $90,000 - $130,000 Contract

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.