This position involves designing and conducting tests, analyzing data, and collaborating with cross-functional teams to ensure that orthopedic devices meet regulatory standards, user requirements, and industry best practices.
- 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 test protocols and procedures for devices, considering factors such as mechanical properties, durability, and biomechanics.
- Conduct a variety of 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 to obtain 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 any anomalies.
- Prepare clear and comprehensive test reports summarizing findings and conclusions.
- Stay up to date 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.
- 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