Electrical Engineer - Medical Device Industry

Position: Electrical Engineer - Medical Device Industry

Location: Ohio City, OH / Raritan, NJ

Contract: 12+ Months

Job Description:   

• Minimum 6–8 years of experience in electrical engineering, with at least 3 years in a medical device or regulated industry.
• Strong knowledge of analog/digital circuit design, Schematics, PCB layout, and troubleshooting.
• Hands on experience on working with Sensors, Drivers, Microcontroller, and different communication methodologies (On Board, Wired, Wireless etc.).
• Experience with medical device standards (IEC 60601, ISO 13485, FDA QSR).

Must Have Technical/Functional Skills

Technical Skills:

• Analog & Digital Circuit Design – Strong design and troubleshooting skills.
• Schematics and PCB Design Layout – Proficient in tools like Altium, OrCAD; knowledge of DFM/DFT.
• Component Engineering – Obsolescence management, alternate sourcing.
• Medical Standards Compliance – IEC 60601, ISO 13485, FDA 21 CFR Part 820.
• Failure Analysis – Root cause analysis (FMEA, 5 Whys, Fishbone).
• Verification & Validation – Test planning, execution, and documentation.
• Embedded Systems (Preferred) – Basic understanding of firmware/hardware integration.
• Documentation & PLM Tools – BOMs, ECOs, DHF; tools like Agile, Windchill.

Functional Skills:

• Sustaining Engineering – Support for legacy products and design updates.
• Cross-Functional Collaboration – Work with QA, RA, Manufacturing, and Supply Chain.
• Regulatory Knowledge – Understanding of global compliance requirements.
• Project Management – Multitasking, prioritization, and milestone tracking.
• Continuous Improvement – Lean/Six Sigma knowledge preferred.

Roles & Responsibilities:

• Lead electrical engineering activities for sustaining and legacy medical device products.
• Investigate and resolve electrical component obsolescence, supplier changes, and field issues.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Support design changes, verification/validation, and documentation updates in compliance with FDA, ISO 13485, and IEC 60601 standards.
• Collaborate with cross-functional teams to ensure timely resolution of product issues and implementation of design improvements.
• Participate in risk assessments (FMEA), design reviews, and change control processes.
• Provide technical support for manufacturing, test engineering, and quality assurance teams.
• Maintain and update technical documentation including schematics, BOMs, test protocols, and reports.
• Ensure compliance with regulatory requirements and internal quality systems.

Generic Managerial Skills, If any

• Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
• Candidate must be able to effectively prioritize and manage multiple activities and responsibilities.
• Ability to understand and follow complex written procedures is required.
• Ability to function in a team environment and deliver on team objectives is required.
• Ability to make decisions and solve problems while exhibiting situational judgement.

Essential Skills: IEC 60601| ISO 13485| FDA 21 CFR Part 820| Circuit Design| PCB Layout| Embedded Systems| MATLAB LabVIEW| Sensors| Drivers| Microcontroller| Electrical Testing| DHF DMR| Risk Management (FMEA)| CAPA| Sustenance Engineering| Design Control Desirable Skills:

Skills: EIS : Medical Device & Regulations~EIS : Embedded Digital Hardware Design and Development Experience Required: 6-8

Education: At least a bachelor’s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required.