Senior Electrical Sustenance Engineer-Medical Devices

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.Salary Range $85000 -$95000 yearsTCS Employee Benefits Summary: Discretionary Annual Incentive. Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans. Family Support: Maternal & Parental Leaves. Insurance Options: Auto & Home Insurance, Identity Theft Protection. Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement. Time Off: Vacation, Time Off, Sick Leave & Holidays. Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.