ECI · 16 hours ago
Sr. Electrical Design Engineer - Medical Device #1889
Newark, DE
Full-time
Onsite
Senior Level
7+ years expECI is a global leader in professional consulting services for the life sciences industry, seeking a Sr. Electrical Design Engineer to design, develop, test, and verify electrical systems within medical devices. The role involves ensuring compliance with safety, performance, and regulatory standards while collaborating with cross-functional teams throughout the product development lifecycle.
BiotechnologyConsultingLife ScienceProject Management
No H1B
Responsibilities
Leads and successfully contributes to design and development project teams typically including the following activities:
Test Method Validation
Electrical System Design: Design and develop electrical circuits, including analog and digital circuits, power supplies, signal processing systems, and data acquisition modules within medical devices
Schematic Capture and PCB Layout: Create detailed electrical schematics and collaborate with PCB designers to ensure proper layout and component placement
Prototype Development: Build and test prototypes of medical devices to validate design concepts and identify potential issues
Verification and Validation Testing: Conduct thorough testing to verify that the electrical systems meet functional requirements and validate their performance against clinical needs
EMC Compliance: Ensure medical device designs comply with Electromagnetic Compatibility (EMC) regulations by conducting necessary testing and mitigation strategies
Risk Management: Identify and mitigate potential electrical safety risks throughout the design process through FMEA analysis and risk assessment
Regulatory Compliance: Adhere to relevant regulatory standards (FDA, IEC) for medical devices, including documentation and reporting requirements
Qualification
Required
Advanced computer skills including MS Office applications (Word/Excel/PowerPoint/Project/Visio/Teams)
Minitab statistical analysis software
Bachelor's Degree in Engineering or equivalent work experience
Minimum of 7 (seven) years direct design experience in medical device industry
Excellent written and verbal communication skills with good presentation and technical writing skills
Collaborative attitude with the ability to work well in a team environment
Strong engineering, design, and analysis skills
Experience with medical devices from concept to commercialization
Understanding of FDA Quality Systems Regulations and EU MDR Regulations
Preferred
SolidWorks experience
Experience with electronic data management system
Some experience with durable medical capital equipment in addition to single-use-devices
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase