Job Title:
Manufacturing Engineer 2 (Test Method Validation)
Reporting to:
Manager, Manufacturing Engineering
Responsibilities:
1. Develop and execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.
2. Validate and implement medical device manufacturing processes as assigned.
3. Identify equipment/fixture installation qualification requirements.
4. Characterization of processes and their outputs/acceptance criteria.
5. Written preparation of applicable validation reports that meet regulatory/company standards.
6. Verification testing.
7. Project management.
8. Maintain accurate and timely reports and records.
Requirements:
* Excellent analytical and problem-solving skills.
* Positive attitude, strong work ethic, and self-motivated.
* Able 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.
* Deputise for Senior Manufacturing Engineer (Test Method Validation).
* Evaluate business decisions against Cook's Code of Conduct.
Qualifications:
* Bachelor's degree in engineering or a related field is desired, 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 the ability to develop strong working relationships.
* Demonstrated problem-solving skills.
* Highly motivated individual, self-starter with a passion for excellence.
* Able to work in a fast-paced environment.
* Excellent attention to detail.