Kaushik Jeevarathinam

•R&D project to design Class III medical device. •Managed a cross-functional team comprising of Mechanical, Electrical and ID engineers. •Worked from Concept creation till Design Verification • Drafted and reviewed all DHF Files such as - Product Requirements, FMEAs, Risk Management Plan and Report, RTM, Hazard Analysis, PQP. Reviewed CERs, Surgical Technique Guides, Design Change Evaluation, CE Marking for EU MDR.

•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.