Vijaykumar Hiremath Email & Phone Number

Mechanical engineer with 5+ years of total experience and 3 years of experience in medical domain handled MDD to MDR compilation and Tech Docs creation for GSPR, Label, Packaging and RA. Worked with EU MDR classes (Ir, IIa instruments and IIb, III Implants). Handled 8 members team as an acting Team lead for design department. Design and Development of Medical Devices and plastic components, worked on One Time used medical device Testing fixture, Jigs and Fixtures (Machining fixture with hydraulic applications), SPM, Electrical Console box with Sheet metal Fabrication, Electromechanical Fixtures and Technical writer.Packaging summary creation for SBS and NSBS for Instruments and Implants with considering the packaging standards and requirements (ISO 11607-1 and ISO 11607-2).❖ Summary creation for Single and Double SBS for applicable single and double dose sterilization such as Gamma, Ethelene Oxide and Gas Plasma.❖ Worst Case Analysis (WCA) creation, for items considering Mass, Sharp, Product protection and cleanliness including oxygen barrier pouches as per the requirement of Materials.❖ Created packaging set-up-sheet for the varies medical items for packaging standard.❖ Redlining of BOM, Prints, WCA and Design verification.❖ Bill of Material change request for existing to new proposed as per requirement.❖ Proposed protective packaging, primary materials, secondary materials and tertiary materials for the MDR implants and instruments as per packaging standards.❖ Understanding device construction and critical functions for One time used medical devices❖ Material selection for the product requirement to medical devices and applying with the DFM/DFA for Design❖ Identifying the Relevant product risk through DFMEA (Tool: Solid works)❖ Development of product considering the Medical Standard ISO 13485 2016 Regulations❖ Identifying the relevant manufacturing process for plastic components❖ Identifying the fixtures requirement for Dis-Assembly, Re-Assembly and Testing and Verification