Sr. Associate I, Research & Development Process & Product Design

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.

Key Responsibilities:

• 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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