Manufacturing Engineer 2: Test Method Validation Specialist
Overview
The role of a Manufacturing Engineer 2 involves the development and execution of test method validations for test equipment per current Quality Management System (QMS) and regulatory standards.
* Validating and implementing medical device manufacturing processes as assigned is a key responsibility.
* Identifying equipment/fixture installation qualification requirements is also crucial.
* Characterizing processes and their outputs/acceptance criteria is essential for quality assurance.
Responsibilities:
Key Responsibilities
* Develop and execute test method validations for test equipment to ensure compliance with QMS and regulatory standards.
* Validate and implement medical device manufacturing processes, ensuring adherence to established protocols.
* Prepare written validation reports that meet regulatory and company standards, providing detailed documentation of processes and outcomes.
* Verify testing project management, ensuring timely and accurate delivery of results.
* Maintain accurate and timely records and reports, supporting continuous improvement initiatives.
Requirements:
Qualifications
* A bachelor's degree in engineering or a related field is desired, with relevant experience considered in lieu of formal education.
* Minimum of three years' validation/relevant experience required, with a strong track record of delivering high-quality results.
* Excellent interpersonal and organizational skills are essential for success in this role.
* Ability to communicate effectively at all levels of the organization, from senior leadership to cross-functional teams.
* Proactive approach to identifying opportunities for improvement, driving positive change through data-driven insights.