Sr. Associate I, Research & Development Process & Product Design
Job Summary
Summary of Position:
TheSenior Associate I Electrical & Electronics (E&E)is responsible forsustaining engineeringsupportforelectrical and electronicsystems forophthalmicmedical devices. This role ensures product continuity compliance and performance throughout the product lifecycle and acts as a technical interfacewithcrossfunctional stakeholders includingSoftware Lifecycle Management (LCM)Design Control Manufacturing Service Quality Regulatory AffairsMedical Safetyand Clinicalteams.
Key Responsibilities:
Electrical Engineerwith strong understanding ofcircuit designand system behavior capable of interpretingschematicsto supportsustaining engineeringactivities such aschange impact analysis failure investigationand technical documentation updates without involvement in new product or circuit design.
Provide subject matter understanding of electrical and electronic systems including PCBAs wiring power systems sensors and interfaces to support analysis and issue resolution.
Review and assessengineering changes (ECOs/ECNs)impactingE&E scope including risk compliance verification and implementation readiness
Supportdesign control activitiesrelated to E&E includingproductrequirements risk analysis verification and traceability
Performroot cause analysisand technical investigationsfor field manufacturing andservicerelatedelectrical issues
Evaluatecomponentchanges obsolescence and supplier impactsand recommend technically sound solutions
Assessmaterial compliance impacts(e.g. RoHS REACH and regionspecific regulations) associated withcomponentand supplier changes
Ensure continuedregulatory and quality compliancethroughout the product lifecycle
Collaborate effectively acrossmechanical software systems manufacturing quality and regulatoryteams to resolve complex issues
Provideengineering judgment and recommendations proposing alternative solutions when
SupportTechnicalfilereviewsand updates ensuringalignmentwithcountyspecificregulatory requirement (e.g.USEU China) in collaboration with Regulatory Affairs.
Supportproductcomplaint investigationsand assess the need for updates toRiskManagementReport(RMR) in collaboration withComplaintsMedicalSafety andDesign Controlteams.
Perform comprehensive engineering design analyses including like-for-likecomponentevaluations electrical and thermal derating assessments tolerance stack-up analysis signal integrity characterization DFM/DFA compliance reviews and EMC/EMI performance analysis to support sustaining engineering and product change activities.
Key Requirements/Minimum Qualifications:
Minimum Requirements
- Bachelors 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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Required Experience:
Senior IC
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.