Job Title: Medical Device Test Engineer
We are seeking a highly skilled and detail-oriented Medical Device Test Engineer to join our fast-paced and innovative team. As a Medical Device Test Engineer, you will be responsible for designing, developing, and executing comprehensive test plans for medical devices to ensure they meet quality and regulatory standards. Your expertise in testing methodologies, equipment, and documentation will be instrumental in assisting our team in delivering safe and reliable medical devices to market.
Responsibilities and Duties:
- Collaborate with cross-functional teams to define test requirements, objectives, and deliverables for medical device projects.
- Design and develop comprehensive test plans, protocols, and reports for medical device validation and verification activities, ensuring compliance with regulations and industry standards.
- Conduct various tests, such as functional, performance, reliability, and usability tests, using advanced testing techniques and equipment.
- Identify, document, and track defects or issues found during testing, and work closely with product development teams to resolve them.
- Perform root cause analysis for test failures and propose viable solutions or design modifications.
- Ensure all test results and related documentation are accurately recorded and maintained in accordance with quality management systems.
- Stay updated with industry standards, regulations, and best practices related to medical devices testing.
- Collaborate with regulatory affairs teams to ensure testing activities are aligned with applicable regulations and standards.
- Participate in risk assessment activities, and provide input for risk mitigation strategies.
- Provide technical guidance and support to colleagues and junior engineers, as needed.
- Contribute to the continuous improvement of testing processes, methodologies, and equipment.
Qualifications and Skills:
- Bachelor's degree in Biomedical Engineering, Electrical Engineering, or a related field. Master's degree is preferred.
- Strong knowledge of medical device regulations, standards, and quality systems (e.g., FDA regulations, ISO 13485, IEC 60601).
- Proven experience working as a Test Engineer within the medical device industry.
- Extensive knowledge of medical device testing methodologies, techniques, and tools.
- Familiarity with risk management processes and tools (e.g., FMEA, fault tree analysis).
- Proficient in using various testing equipment and software.
- Ability to design and develop comprehensive test plans, protocols, and reports.
- Excellent analytical and problem-solving skills.
- Strong attention to detail and ability to work in a fast-paced environment.
- Excellent communication and interpersonal skills.
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