Manufacturing Engineer 2 (Test Method Validation)
The Manufacturing Engineer 2 performs and documents validations of medical device manufacturing processes.
Responsibilities
* 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.
Key Skills
* 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.
* 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.
Qualifications
* 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.