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Process Engineer I

Trisalus Life Sciences, Inc.
Westminster, CO Full Time
POSTED ON 12/9/2024
AVAILABLE BEFORE 2/9/2025

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 preferred 

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