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.

Responsibilities:

Strong background in many areas, such as programming (machine language/software), electronics, and mechanical test equipment.Experience operating and maintaining test equipment such as MTS, Instron, and other test equipment related to mechanical and wear testing in medical devices.
Solid background in Mechanics of Materials (i.e. with plastics and metals alloys such as Ti, CoCr, SS and UHMWPE).
Collaborate with product development teams to understand device specifications, intended use, and performance requirements.
Design and develop device test protocols and procedures, considering mechanical properties, durability, and biomechanics.
Conduct various tests on orthopedic devices, such as mechanical testing, fatigue testing, wear testing, and biomechanical analysis.
Perform testing using specialized equipment, instrumentation, and testing fixtures. Maintain accurate and organized records of testing procedures, data, and results.
Ensure adherence to test protocols and standards for accurate and reliable results.
Collect and record test data, including measurements, observations, and relevant parameters.
Analyze test results to assess device performance, identify trends, and detect anomalies.
Prepare clear and comprehensive test reports summarizing findings and conclusions.
Stay current with relevant regulatory standards (e.g., FDA, ISO) and industry guidelines for orthopedic medical device testing. Attend industry meetings and work at test houses as needed.
Ensure that testing processes and documentation adhere to regulatory requirements.
Collaborate closely with design engineers, R&D teams, and quality assurance personnel to address testing-related issues and incorporate feedback into device design.
Communicate test results, findings, and recommendations effectively to cross-functional teams and stakeholders.

Qualifications:

Bachelor's or higher degree in mechanical engineering, biomedical engineering, or a related field.
Strong understanding of orthopedic medical devices, anatomy, and biomechanics.
Proficiency in designing and executing mechanical tests, such as tensile, compression, and fatigue testing. Wear testing experience desired.
Familiarity with relevant standards and regulations, such as ASTM, ISO, and FDA guidance documents.
Experience with test equipment and instrumentation used in orthopedic device testing.
Analytical skills to interpret test data, identify trends, and draw meaningful conclusions.
Understanding of statistical analysis and expertise with Minitab Statistical Analysis Software.
Strong communication skills to collaborate effectively with cross-functional teams.
Attention to detail and a commitment to maintaining the highest quality standards.
Previous experience in orthopedic medical device testing or a related field is a plus.
Strong technical writing skills

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