Senior Electrical Engineer - Medical Devices

Role - Senior Electrical Engineer - Medical Devices

Location - Ohio City, OH / Raritan, NJ (Onsite)

Exp need - 6+ years

Job Description

• Blue Ash, OH • 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.

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.

Role Descriptions

• 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.

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

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.