Electrical Engineer

Role: Electrical Engineer
Location: Blue Ash, OH
Duration: 6 Months

Role Description:
Bachelor's or master's degree in electrical engineering or related field.
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 working with sensors, drivers, microcontrollers, 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:

• Strong communication skills.
• Candidates must be highly proficient in reading, writing, and speaking English language.
• 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.