Provide subject matter expertise for electrical and electronic systems , including PCBAs, electrical assemblies, wiring, power systems, sensors, and interfaces
Review and assess engineering changes (ECOs/ECNs) impacting E&E scope, including risk, compliance, verification, and implementation readiness
Support design control activities related to E&E, including requirements, risk analysis, verification, and traceability
Perform root cause analysis and technical investigations for field, manufacturing, and service‑related electrical issues
Evaluate component changes, obsolescence, and supplier impacts and recommend technically sound solutions
Assess material compliance impacts (e.g., RoHS, REACH, and region‑specific regulations) associated with component and supplier changes
Ensure continued regulatory and quality compliance throughout the product lifecycle
Collaborate effectively across mechanical, software, systems, manufacturing, quality, and regulatory teams to resolve complex issues
Provide engineering judgment and recommendations , proposing alternative solutions when required
Support Technical file reviews and updates, ensuring alignment with county specific regulatory requirement (e.g., US, EU, China) , in collaboration with Regulatory Affairs.
Support product complaint investigations and assess the need for updates to Risk Management Report (RMR) , in collaboration with Complaints, Medical Safety and Design Control teams.
Key Requirements/Minimum Qualifications:
Minimum Requirements
Bachelor's degree in Electrical / Electronics Engineering or a related discipline
5+ years of experience in medical device sustaining engineering or product development
Preferred Experience
Experience supporting embedded electronic systems
Proficiency with PLM and requirements tools (e.g., Windchill, Polarion, Teamcenter)
Working knowledge of systems engineering principles and interface management
Exposure to surgical or ophthalmic medical devices
Familiarity with medical device standards such as ISO 13485, ISO 14971 , and awareness of electrical safety and EMC requirements (e.g., IEC 60601 series).
KNOWLEDGE, SKILLS & BEHAVIORS
Strong analytical and structured problem-solving skills
Ability to work independently with moderate autonomy while following defined processes
Effective communicators in cross functional and global environments
Collaborative team player with ownership mindset
Product lifecycle and business awareness
Quality driven, compliance focused approach
Work hours: 1 PM to 10 PM IST
Relocation assistance: Yes
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Additional Information
Summary of Position:
The Senior Engineer I - Electrical & Electronics (E&E) is responsible for sustaining engineering support for electrical and electronic systems for ophthalmic medical devices . This role ensures product continuity, compliance, and performance throughout the product lifecycle and acts as a technical interface with cross functional stakeholders including Software Lifecycle Management (LCM), Design Control, Manufacturing, Service, Quality, Regulatory Affairs, Medical Safety and Clinical teams.
Alcon · Bangalore, India