Manufacturing Engineer 2 (Test Method Validation)

Cook Medical

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

Reporting to: Manager, Manufacturing Engineering.

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 relevant experience.
Minimum of 3 years’ Validation/relevant experience is required.
Strong interpersonal and organisational skills and the ability to communicate at all levels of the organisation.
Willingness to seek out and drive improvement.
Proven project planning skills and the ability to execute projects in a timely and effective manner.
Team Player with ability to develop strong working relationships.
Demonstrated problem solving skills. Highly motivated individual, self-starter with a passion for excellence.
Must be able to work in a fast-paced environment.
Excellent attention to detail.

Don't forget to mention EuroEngineerJobs when applying.

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