Electrical Engineer with PCB - Medical Devices--Onsite in Blue Ash, Ohio with TCS

[akash goyal]

Hi,

Please find the below job description:

Role Descriptions:

· 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 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

· 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.

Desirable Skills:

Keyword:

Skills: ISO 13485, Medical Device & Regulations, Embedded Digital Hardware Design and Development

Experience Required: 6-8