Seeking an Electrical Engineer for design/testing of medical device components. Role involves DVT, data analysis, and collaboration with multiple teams.
This is a remote position.
We are seeking a highly skilled and detail-oriented Electrical Engineer to support the design, testing, and validation of electrical components for active implantable medical devices and related hardware systems. The ideal candidate will have hands-on experience in product development, particularly through design verification testing (DVT) and the transition into production-scale manufacturing. This role requires strong analytical skills, technical leadership, and the ability to collaborate with cross-functional teams in a regulated environment.
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- Lead and execute electrical design verification testing (DVT) activities for implantable and external medical devices.
- Develop and document test protocols, test plans, and verification procedures in compliance with quality and regulatory standards.
- Perform bench testing using standard electrical engineering laboratory equipment (oscilloscopes, multimeters, function generators, etc.).
- Analyze and interpret test data; summarize findings and provide clear technical documentation.
- Coordinate and track test investigations, ensuring timely completion and documentation accuracy.
- Lead or support failure analysis and root cause investigations for test nonconformances and component issues.
- Work closely with R&D, Quality, Manufacturing, and Systems Engineering teams to resolve technical challenges and ensure design robustness.
- Support yield improvement activities, identifying and implementing process or design enhancements.
- Maintain strict adherence to design control and quality system requirements, ensuring full traceability and compliance with FDA, ISO 13485, and IEC standards.
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- Bachelor’s degree in Electrical Engineering or related discipline with professional experience in electrical engineering in medical device product development or a highly regulated industry.
- Proven experience in the DVT phase of product development and transition to manufacturing.
- Strong background in data analysis using Minitab, JMP, or Microsoft Excel.
- Demonstrated ability to lead and close projects involving cross-functional collaboration.
- Experience performing bench-level testing and troubleshooting using standard EE test instruments.
- Excellent technical documentation, communication, and problem-solving skills.
- Proven ability to manage multiple priorities while maintaining attention to detail and compliance.
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- Experience with active implantable or Class III medical devices.
- Knowledge of IEC 60601, ISO 14708, and FDA Design Control (21 CFR 820.30) standards.
- Familiarity with SPICE simulation tools, PCB design and layout, or circuit debugging.
- Experience with root cause analysis, FMEA, and CAPA methodologies.
- Demonstrated success in yield improvement initiatives and process optimization.
This is intended for inclusion in Pharmavise’s talent database to build a qualified pool of professionals for future medical device client requisitions.
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