Development Operations Manager

21 hours ago


Westminster, Colorado, United States Trisalus Life Sciences, Inc. Full time
Job Description

Trisalus Life Sciences, Inc. is seeking a talented Development Operations Manager to support process development activities for new products and existing product lines in accordance with FDA and international regulations.

The successful candidate will have experience in developing, validating, implementing and improving processes for the manufacture of medical devices, as well as characterizing custom equipment focused on reducing manufacturing/testing variability.

  • Expected Salary: $100,000 - $130,000 per year
Key Responsibilities

Key responsibilities include working with R&D engineering and manufacturing team on New Product Introduction, developing, validating, implementing and improving processes for the manufacture of medical devices, characterizing custom equipment focused on reducing manufacturing/testing variability, creating specifications for and validating test equipment, conducting testing of product and analyzing data as needed.

Main Responsibilities:

  • Process Development: Support process development activities for new products and existing product lines in accordance with FDA and international regulations
  • Team Collaboration: Work with R&D engineering and manufacturing team on New Product Introduction
  • Process Improvement: Develop, validate, implement and improve processes for the manufacture of medical devices
  • Equipment Optimization: Characterize custom equipment focused on reducing manufacturing/testing variability
  • Test Equipment Validation: Create specifications for and validate test equipment, conduct testing of product and analyzing data as needed

Requirements:

  • 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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