Summary of Position:
The Senior Associate 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.
Key Responsibilities:
- Support existing electrical and electronic products through board-level testing, troubleshooting, schematic review, failure investigation, and technical documentation updates. This role “does not” include new products or circuit/schematic design activities.
- Use knowledge of electronic boards, wiring, power supplies, sensors, and electrical interfaces to identify and resolve product issues.
- 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 product 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 electrical and electronic product changes continue to meet quality and regulatory requirements.
- 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.
- Perform engineering assessments for sustaining activities, including equivalent component evaluations, electrical and thermal derating, tolerance analysis, signal integrity, manufacturability and assembly reviews, and EMC/EMI analysis.
Key Requirements/Minimum Qualifications:
Minimum Requirements
- Bachelor’s degree in Electrical and Electronics Engineering (EEE) or Electronics and Communication Engineering (E&C)
- 5+ years of experience in medical device sustaining engineering, product support 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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