Job Description
Duties and Responsibilities:
* Support process development activities for 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.
Qualifications
Education & Certifications:
* Minimum of four year engineering degree or equivalent experience.
Work Experience:
* Minimum of 0-2 years of experience in medical device process development required.
* FDA regulated work experience required.
* Lean Six Sigma certification.
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