Product Evaluations Engineer

1 week ago


Wheat Ridge, Colorado, United States BDC Laboratories Full time
Job Overview

BDC Laboratories is a leading provider of medical device testing services, design verification test equipment, and silicone mock vessels to the medical device community. We are seeking a highly skilled Product Evaluations Engineer to join our team.


Key Responsibilities
  • Prepare and execute studies to ensure compliance with applicable standards and company quality system requirements.
  • Develop and maintain protocols, test methods, and validation procedures.
  • Ensure all data generated during laboratory studies is accurately recorded and documented.
  • Perform data analysis and create software scripts and templates to perform data analysis.
  • Manage projects to ensure timely completion, within budget, and to the satisfaction of customers.
  • Participate in regulatory inspection activities with regulatory agencies.
  • Apply good testing practices and maintain a clean and organized laboratory environment.

Requirements
  • Minimum of a Bachelor's Degree in an engineering field or a science-based field with relevant experience.
  • Understanding of quality system requirements, including ISO 17025 and 21 CFR part 58.
  • Excellent analytical and problem-solving abilities, with the ability to perform and report basic statistical analysis.
  • Ability to read, analyze, and interpret technical procedures and governmental regulations.
  • Good verbal and writing skills, with the ability to effectively present information and respond to questions from managers and team members.

BDC Laboratories is an equal opportunity employer.

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