Role Description:
Senior Electrical Sustenance Engineer responsible for supporting legacy medical device products through electrical design improvements, troubleshooting, component lifecycle management, verification/validation activities, and regulatory compliance.
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 electrical design changes, verification/validation, and documentation updates.
- Ensure compliance with medical device standards including IEC 60601, ISO 13485, and FDA 21 CFR Part 820.Perform risk assessments, FMEA, design reviews, and change control activities.
- Provide technical support to manufacturing, test engineering, and quality teams.
- Maintain and update technical documentation including schematics, BOMs, test protocols, and reports.
- Collaborate with QA, Regulatory Affairs, Manufacturing, and Supply Chain teams.
- Support continuous improvement initiatives and product reliability enhancements.
- Required Technical Skills
- Electrical Engineering
- Analog and Digital Circuit Design
- Electrical Troubleshooting and Testing
- Schematics Design and PCB LayoutAltium / OrCAD ToolsDFM/DFT Knowledge
- Sensors, Drivers, Microcontrollers
- Wired and Wireless Communication Methods
- Embedded Systems and Hardware/Firmware Integration
- Medical Device & QualityIEC 60601ISO 13485FDA 21 CFR Part 820 Design Controls
- Verification & Validation (V&V)
- Risk Management (FMEA, 5 Whys, Fishbone)CAPADHF / DMR DocumentationECO and Change Control Processes
- Tools & Additional SkillsPLM Tools (Agile, Windchill)BOM ManagementMATLAB / LabVIEWElectrical Test Documentation
- Lean/Six Sigma Knowledge Preferred
- Professional SkillsStrong communication and documentation skills.
- Ability to manage multiple priorities and work in a regulated environment.
- Strong problem-solving and decision-making abilities.
- Ability to collaborate effectively with cross-functional teams.
- Experience Required6–8 years of electrical engineering experience.
- Minimum 3 years of experience in medical device or regulated industry.
- Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or related field. what should be the tittle
