Sr. Electrical Design Engineer - Medical Device #1889
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the role The Sr. Electrical Engineering consultant is responsible for designing, developing, testing, and verifying the electrical systems within medical devices, ensuring they meet safety, performance, and regulatory standards while working closely with cross-functional teams throughout the product development lifecycle, from concept to commercialization, to create innovative and reliable healthcare solutions for patients. What you will do: 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.
What You Will Bring:
- Advanced computer skills including MS Office applications
- Word/Excel/powerpoint/project/visio/Teams)
- Minitab statistical analysis software
- SolidWorks experience preferred. Experience with electronic data management system.
- Bachelor’s Degree in Engineering or equivalent work experience.
- Minimum of 7 (seven) years direct design experience in medical device industry
- Some experience with durable medical capital equipment in addition to single-use-devices is preferred.
- 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
ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. Apply tot his job Apply To this Job