Senior Manufacturing Engineer (Test Method Validation)
Reports to: Manager, Manufacturing Engineering
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.
* Characterize processes and their outputs/acceptance criteria.
* Prepare written validation reports that meet regulatory/company standards.
* Verify testing.
* Manage projects.
* Maintain accurate and timely reports and records.
Requirements:
* Excellent analytical and problem-solving skills.
* Positive attitude, strong work ethic, and self-motivation.
* 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.
* Delegate for Manufacturing Engineering Manager and the Senior Test Engineer.
* Ensure that Cook's Code of Conduct is considered in all business matters carried out on Cook's behalf.
Qualifications:
* Bachelor's degree desired, preferably in engineering or a related field, and/or relevant experience.
* Minimum of 5 years' Validation/relevant experience 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.
* Ability to work in a fast-paced environment.
* Excellent attention to detail.