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.
Key Responsibilities
• 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 .
Must-Have Qualifications
• 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.
Preferred Qualifications
• 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.