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Senior Product Development Engineer
3 weeks ago
This role entails developing and executing test method validations for test equipment in accordance with current QMS/Regulatory standards.
- Develop and execute test method validations for test equipment per current QMS/Regulatory standards.
- Implement medical device manufacturing processes as assigned.
- Determine the requirements for equipment fixture installation qualification.
- Characterize processes and their outputs/acceptance criteria.
- Prepare written validation reports that meet regulatory/company standards.
- Verify testing, manage projects and maintain accurate and timely records.
Requirements
- Excellent analytical and problem-solving skills.
- Strong work ethic, self-motivated and positive attitude.
- Ability to handle multiple projects simultaneously.
- Maintain training requirements for the position and seek opportunities for continuous development.
- Promote accurate documentation consistent with pertinent regulations and quality management systems.
- Assist senior manufacturing engineers and uphold a code of conduct.