What are the responsibilities and job description for the Medical Device Testing Engineer position at EnIn Systems?
Job Summary:
We are seeking a skilled Medical Device Testing Engineer to plan, execute, and document comprehensive testing of medical devices in compliance with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and IEC 60601. The ideal candidate will have hands-on experience with verification and validation (V&V) processes, risk-based testing, and product safety evaluations.
Key Responsibilities:
- Develop and execute test protocols (IQ/OQ/PQ, V&V) for medical devices and embedded systems.
- Conduct functional, performance, safety, and reliability testing as per regulatory requirements.
- Collaborate with product development, quality, and regulatory teams to align testing activities with design control processes.
- Review design requirements, risk analyses, and use cases to develop test plans and test cases.
- Document test results, deviations, and issues in accordance with Good Documentation Practices (GDP).
- Perform failure investigations, root cause analyses, and support CAPA implementation.
- Ensure compliance with standards including FDA 21 CFR 820, ISO 13485, IEC 60601, ISO 14971, and IEC 62304.
- Operate and calibrate test equipment like oscilloscopes, analyzers, and environmental chambers.
- Prepare detailed test reports for internal reviews, audits, and regulatory submissions.
- Participate in internal and external audits, supporting validation and testing documentation reviews.
Required Skills & Qualifications:
- Bachelor’s degree in Biomedical Engineering, Electrical Engineering, or a related field.
- 6 years of medical device testing or validation experience in regulated environments.
- Strong knowledge of FDA, ISO, and IEC standards applicable to medical devices.
- Experience in electrical, mechanical, software, or usability testing of medical products.
- Familiarity with risk management (ISO 14971) and Design Control processes.
- Proficient in report writing, test documentation, and deviation reporting.
Preferred Qualifications:
- Experience with automated testing frameworks and data acquisition systems.
- Knowledge of embedded systems testing and software V&V.
- Certifications such as CQE, CQA, or RAC are a plus.
- Hands-on experience with HPLC, environmental chambers, or mechanical fatigue testers (if applicable).
