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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