Manufacturing Engineer 2 (Test Method Validation)

The Manufacturing Engineer 2 (Test Method Validation) performs and documents validations of medical device manufacturing processes.

Reporting to: Manager, Manufacturing Engineering  

Find out more about Cook Medical here

• Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.
• Validate and implement medical device manufacturing processes as assigned.
• Identify equipment/fixture installation qualification requirements.
• Characterization of processes and their outputs/acceptance criteria.
• Written preparation of applicable validation reports that meet regulatory/company standards.
• Verification testing
• Project management
• Maintain accurate and timely reports and records
• Must have excellent analytical and problem solving skills
• Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook’s Quality Management System where applicable.
• Deputise for Senior Manufacturing Engineer (Test Method Validation)
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

∙ Bachelor’s degree is desired, preferably in engineering or a related field and / or