remote
Electrical Engineer - Pharmavise Corporation
Software Engineer
Electrical Engineer role focused on design verification testing (DVT) for implantable medical devices, requiring expertise in electrical design, regulatory compliance, and manufacturing transition in a remote, cross‑functional environment.
About the role
This is a remote position.
- Lead and executeelectrical design verification testing (DVT)activities for implantable and external medical devices.
- Develop and documenttest protocols, test plans, and verification proceduresin compliance with quality and regulatory standards.
- Performbench testingusing standard electrical engineering laboratory equipment (oscilloscopes, multimeters, function generators, etc.).
- Analyze and interpret test data; summarize findings and provide clear technical documentation.
- Coordinate and tracktest investigations, ensuring timely completion and documentation accuracy.
- Lead or supportfailure analysis and root cause investigationsfor test nonconformances and component issues.
- Work closely withR&D, Quality, Manufacturing, and Systems Engineeringteams to resolve technical challenges and ensure design robustness.
- Supportyield improvement activities, identifying and implementing process or design enhancements.
- Maintain strict adherence todesign control and quality system requirements, ensuring full traceability and compliance withFDA, ISO 13485, and IEC standards.
- Bachelor’s degree in Electrical Engineeringor related disciplinewith professional experience inelectrical engineering inmedical device product developmentor a highly regulated industry.
- Proven experience in theDVT phaseof product development and transition to manufacturing.
- Strong background indata analysisusingMinitab, JMP, or Microsoft Excel.
- Demonstrated ability to lead and close projects involvingcross-functional collaboration.
- Experience performingbench-level testing and troubleshootingusing standard EE test instruments.
- Excellenttechnical documentation, communication, and problem-solvingskills.
- Proven ability to manage multiple priorities while maintaining attention to detail and compliance.
- Experience withactive implantable or Class III medical devices.
- Knowledge ofIEC 60601,ISO 14708, andFDA Design Control (21 CFR 820.30)standards.
- Familiarity withSPICE simulation tools,PCB design and layout, orcircuit debugging.
- Experience withroot cause analysis, FMEA, and CAPA methodologies.
- Demonstrated success inyield improvement initiativesand 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.
Originally posted on Himalayas