Validation Engineer

Purpose of the job:

The validation engineer is responsible for designing, communicating and implementing an operational plan for completing engineering-based projects. Prepares designs, project controls and specifications, schedules, installation, testing and commissioning of new equipment, tooling, lines, fixtures, etc. Monitors progress and performance against the project plan.

Responsibilities:

• Provide support in Installation and Setup of Manufacturing lines within the scope of the project
• Generation of documentation for equipment calibration/maintenance per internal procedures
• Provide support to complete equipment validation activities IQ/OQ/TMV of equipment and production fixtures
• Create and update test protocols as well as execution of protocols
• Assist with line transfer activities between suppliers as well as inter-company transfers
• Support and coordination of documentation release (protocols, reports and supporting documentation) in CPDM/Windchill
• Support in creating software validation requirements, and corresponding validation
• Support generation or update of documentation as necessary for the implementation
• Work with manufacturers to ensure timely repairs and part replacement for seamless execution

Requirements:

• 4 years of experience as a Validation Engineer or related field
• Advanced English
• Engineering, any specialty
• Leadership experience.
• Experience of catheters and medical device companies.
• Experience using measuring and testing equipment associated with specific discipline.
• Experience reading and understanding technical documentation associated with specific discipline.