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Medical Device Test Engineer

2 months ago

Miami, United States MedTech Healthcare Consultants Full time
Job Summary:

This position involves designing and conducting tests, analyzing data, and collaborating with cross-functional teams to ensure orthopedic devices meet regulatory standards, user requirements, and industry best practices.

Key Responsibilities:

  • Design and Conduct Tests: Develop and execute test protocols and procedures for orthopedic devices, considering mechanical properties, durability, and biomechanics.
  • Collaborate with Cross-Functional Teams: Work closely with product development teams to understand device specifications, intended use, and performance requirements.
  • Analyze Test Results: Collect and record test data, including measurements, observations, and relevant parameters, and analyze results to assess device performance, identify trends, and detect anomalies.
  • Prepare Test Reports: Prepare clear and comprehensive test reports summarizing findings and conclusions.
  • Stay Current with Regulatory Standards: Ensure adherence to relevant regulatory standards (e.g., FDA, ISO) and industry guidelines for orthopedic medical device testing.
  • Communicate Effectively: Communicate test results, findings, and recommendations effectively to cross-functional teams and stakeholders.

Qualifications:

  • Education: Bachelor's or higher degree in mechanical engineering, biomedical engineering, or a related field.
  • Experience: Strong background in mechanical testing, biomechanics, and orthopedic medical devices.
  • Skills: Proficiency in designing and executing mechanical tests, such as tensile, compression, and fatigue testing. Wear testing experience desired.
  • Knowledge: Familiarity with relevant standards and regulations, such as ASTM, ISO, and FDA guidance documents.
  • Analytical Skills: Strong analytical skills to interpret test data, identify trends, and draw meaningful conclusions.
  • Communication Skills: Strong communication skills to collaborate effectively with cross-functional teams.
  • Attention to Detail: Attention to detail and a commitment to maintaining the highest quality standards.