Project Engineer, Medical
EPM is collaborating with a leading medical device company in the USA to find a skilled Engineer specializing in the evaluation and testing of medical electrical devices. This role is crucial in ensuring products meet regulatory standards and industry requirements.
Role Overview
The Engineer will be responsible for conducting assessments and tests on medical electrical devices, ensuring compliance with relevant industry standards. This role involves working closely with clients to create tailored test plans, troubleshooting compliance issues, and supporting laboratory operations.
Key Responsibilities
- Perform testing and evaluation of medical electrical devices according to industry standards (e.g., IEC 60601-1 and IEC 60601-2-x), with the ability to implement updates as regulations evolve.
- Collaborate with clients to design and adjust testing plans to meet specific requirements.
- Review and assess quality management systems following ISO 13485 guidelines.
- Conduct risk assessments in line with ISO 14971.
- Assist in setting up and troubleshooting compliance tests.
- Work alongside laboratory teams to coordinate sample handling, preparation, and testing procedures.
- Maintain, calibrate, and troubleshoot laboratory equipment to ensure proper functionality.
Required Qualifications & Experience
- A Bachelor's degree in Electrical Engineering or a related field.
- At least three years of experience in product testing and certification, preferably within the medical device industry.
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