Kaushik Jeevarathinam

Led requirements analysis and migration of Design Control documentation into Polarion for ophthalmic and SiMD products, identifying deficiencies and establishing requirements with improved traceability. As CQE,Strengthened Risk Management–Design Controls integration through risk analysis, risk-control activities and Polarion traceability. Facilitated Design Reviews across NPD stages Supported MBSE implementation by developing ophthalmic architecture in MagicDraw, structuring system elements and interfaces

Led a cross-functional R&D project for the development of Class III medical devices, coordinating Mechanical, Electrical, and Industrial Design disciplines from concept development through Design input stage. Contributed as a primary inventor for novel device concepts developed as part of an IP-focused product development initiative. Aided in Concept selection and development; Developed and implemented a robust Defect Management System resulting in a collective time savings of over 1000 hours.

•Worked in a Class III medical device New Product Development project as DQE from Concept development till Design Validation. •Authored Risk documents, Test Method Validation (TMV) Protocols and Reports, DV plan and reports, used Minitab. •Experienced in working with hand tools, gages, pressure and force gage testing, fixture design and microscopes. •Created Risk Management documents such as Risk Management Plan and Report, Hazard Analysis, Design/Use Failure Mode Effect Analysis (D/UFMEA) documents

•Carried out a Design Verification and Design Validation gap analysis for several legacy products on existing Technical Files/Design Dossiers against updated Medical Device Reporting requirements. •Revised Design Controls and Risk Management documents •Achievement: Efficiently cleared a substantial backlog of Gap Assessments, leading to a transfer to Abbott Headquarters to share expertise and knowledge gained from the process.