Job Title: Senior Manufacturing Engineer (Test Method Validation)
Overview
The Senior Manufacturing Engineer will be responsible for developing and executing Test Method Validations for Test Equipment per current QMS/Regulatory standards. They will validate and implement medical device manufacturing processes as assigned, identify equipment/fixture installation qualification requirements, characterize processes and their outputs/acceptance criteria, and prepare written validation reports that meet regulatory/company standards.
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.
* Verification testing.
* Project management.
* Maintain accurate and timely reports and records.
Requirements
* Bachelor's degree in engineering or a related field.
* Minimum of 5 years' Validation/relevant experience.
* 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.