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Medical Device Testing Professional

2 weeks ago


Houston, Texas, United States Biotex Inc Full time

Career Opportunity

Biotex Inc is dedicated to pioneering medical and bio-technologies. We collaborate with startups, established companies, and entrepreneurs to develop and manufacture innovative medical devices.

Role Description

Our Criterion team is seeking a skilled Test Engineer II to join us in Houston, TX. As a key member of the team, you will contribute to test engineering, test execution, creating test cases, testing, and functional testing within the medical device development and manufacturing environment.

Key Functions:

  • Develop and implement comprehensive test plans aligned with regulatory requirements.
  • Establish and maintain testing equipment, including creating and updating operating procedures.
  • Provide guidance and mentorship to test technicians as needed.
  • Analyze and troubleshoot issues with test equipment and equipment under test.
  • Evaluate proposed design changes and offer recommendations to product development teams.
  • Conduct advanced engineering tasks related to product safety, EMC, packaging, verification, and validation (V&V).
  • Participate in projects involving the development, fabrication, and production of complex medical components, systems, or processes.
  • Develop, integrate, verify, and validate testing methodologies.
  • Travel occasionally for training or project facilitation (approximately 10%).

Required Skills:

  • Must have prior experience with IEC 60601-1 testing.
  • Self-motivated individual with high integrity and strong work ethic.
  • Technical expertise in product safety, EMC, packaging, or medical V&V testing principles.
  • Superior organizational skills and attention to detail.
  • Excellent written and verbal communication and documentation abilities.
  • Proactive problem-solving approach.
  • Ability to work effectively with cross-functional teams and establish strong working relationships.
  • Familiarity with external certification agencies and regulations affecting the medical device industry is an asset.