Electrical Engineer (Medical Device Industry) - Intellectt INC

Job Title: Electrical Engineer (Medical Device Industry)
Duration: 12+ Months (W2)

Job Description:
We are looking for a talented Electrical Engineer with experience in the medical device industry. In this role, you'll support the design, testing, and validation of electronic systems and components within medical devices, ensuring compliance with regulatory standards and high-quality manufacturing requirements.

Key Responsibilities:
Electrical Design & Development: Design and develop electronic systems and components for medical devices, including PCB layout, circuit design, and prototyping.
Testing & Validation: Conduct tests and validation protocols (IQ/OQ/PQ) to ensure that designs meet performance, reliability, and compliance standards.
Troubleshooting & Optimization: Diagnose issues in electrical systems and components, implement improvements, and resolve failures in design and manufacturing stages.
Documentation: Prepare and maintain engineering documentation, including design specifications, test protocols, and risk assessments, in accordance with regulatory requirements.
Regulatory Compliance: Ensure designs comply with FDA regulations (21 CFR Part 820), ISO 13485, IEC 60601, and other applicable standards.
Cross-functional Collaboration: Work closely with cross-functional teams, including mechanical engineers, quality assurance, and production teams, to integrate electrical components seamlessly.

Qualifications:
Education: Bachelor's degree in Electrical Engineering, Electronics Engineering, or a related field.
Experience: 3+ years of experience in electrical engineering within the medical device industry.
Regulatory Knowledge: Familiarity with FDA regulations, ISO 13485, and IEC 60601 standards.
Technical Skills: Proficiency in circuit design software (e.g., Altium, OrCAD), PCB layout, and CAD tools.
Analytical Skills: Strong problem-solving and troubleshooting abilities with experience in root cause analysis.
Communication Skills: Excellent written and verbal communication skills for documentation and teamwork.