Process Engineer I
4 months ago
- Support process development activitiesfor new products and existing product lines in accordance with FDA and international regulations
- Work with R&D engineering and manufacturing team on New Product Introduction
- Develop, validate, implement and improve processes for the manufacture of medical devices
- Characterize custom equipment focused on reducing manufacturing/testing variability
- Create specifications for and validate test equipment, conduct testing of product and analyzing data as needed
- Constantly identify opportunities to reduce waste and process variation. Develop and implement plans to capitalize on these opportunities.
- Develop and improve standard operating procedures for process development and validation
- Create and maintain process validation master plan
- Follow approved procedures for activities conducted and update or generate new procedures as needed
- Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485
- Assure individual and group safety when conducting all activities
- Maintain effective communications with supervisor and peers in project activities
- Support manufacturing activities, as necessary
- Present information across multiple departments to provide project and product updates
Education & Certifications:
- Minimum of four year engineering degree or equivalent experience
- Minimum of 0-2 years of experience in medical device process development required
- FDA regulated work experience required
- Lean Six Sigma certification preferred
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