As New Product engineer, I am involved in primary Product Life and Design Cycle. Development of new product (implant) along with necessary instrumentation and accessories involves the following steps:- Background research of market and competition analysis- Ideation of product and identification of predicate device, technical feasibility and costs- Generating concept and primary design based on study of anatomy, biomechanical forces and pathology, surgical technique and… Show more As New Product engineer, I am involved in primary Product Life and Design Cycle. Development of new product (implant) along with necessary instrumentation and accessories involves the following steps:- Background research of market and competition analysis- Ideation of product and identification of predicate device, technical feasibility and costs- Generating concept and primary design based on study of anatomy, biomechanical forces and pathology, surgical technique and guidelines- Selection of materials based on design and application- 3D CAD modeling using SolidWorks or SolidEdge, drafting, dimensioning and tolerances- 3D printing and prototyping, design modifications (if any)- Calculation of material order quantity, sourcing of special order materials (if any)- Machining and manufacturing sequence, design of jigs and fixtures (if any)- Inspection check sheets, testing methodology as per ISO, ASTM testing standards, design and manufacturing of test jigs and fixtures- Preparation of Design History file and Technical file as per ISO 13485, EU MDR and Indian FDA- Design and manufacturing of related surgical instruments, design and layout of instrumentation containers, special product packaging (if any) Show less

S. H. Pitkar Orthotools is a ISO 9001, ISO 13485, CE and Indian FDA certified company. Following were my Roles and Responsibilities:- Reading and understanding ISO standards, EU MDR, GSR 78E, Apex Manuals, SOPs and Technical Files. - Undertaking annual Internal Audits of 5 departments for ISO 9001 and ISO 13485 and generating reports for top management with non-compliances, if any. - Updating technical IFUs and Operative Guidelines for certain products.- Documentation of new… Show more S. H. Pitkar Orthotools is a ISO 9001, ISO 13485, CE and Indian FDA certified company. Following were my Roles and Responsibilities:- Reading and understanding ISO standards, EU MDR, GSR 78E, Apex Manuals, SOPs and Technical Files. - Undertaking annual Internal Audits of 5 departments for ISO 9001 and ISO 13485 and generating reports for top management with non-compliances, if any. - Updating technical IFUs and Operative Guidelines for certain products.- Documentation of new products, generating Design History File as per ISO 13485, Technical File for CE and Indian FDA.- Documentation for application of US FDA 510K, especially for Software used with Hardware, as per 21CFR Show less

As part of my Bachelor's Degree Project, I worked on the "Design and Fabrication of Clamp Type Rotameter Test Rig". This entailed the following:- Understanding casting defects in Rotameters- Understanding current test rig and drawbacks- Design of alternate test rig that eliminates buckling stresses, reduces time and more ergonomic to reduce operator fatigue- Design of fixtures for smaller and varied geometry test pieces- DFS, DFM, DFQ, DFA using mehcanical claculations… Show more As part of my Bachelor's Degree Project, I worked on the "Design and Fabrication of Clamp Type Rotameter Test Rig". This entailed the following:- Understanding casting defects in Rotameters- Understanding current test rig and drawbacks- Design of alternate test rig that eliminates buckling stresses, reduces time and more ergonomic to reduce operator fatigue- Design of fixtures for smaller and varied geometry test pieces- DFS, DFM, DFQ, DFA using mehcanical claculations and analysis on ANSYS- Detailed design drawings using 2D and 3D modeling- Undestanding design of hydraulic and pneumatic circuits, control panel- Making manufacturing process charts- Writing SOP for test on the designed test rig Show less

Design and Development of Torque Wrench for Spinal Implant Kit- Reverse engineering, identifying past design and drawbacks- Design modification based on implant application, calculation of torque and change in mechanism- 3D modeling on ProEngineer, CNC Programming Project successfully designed and is being sold by the company.CNC machining- CNC Programming for manufacturing of Grub Screw on Citizen and FANUC controllers- Involved in the design and CNC milling of… Show more Design and Development of Torque Wrench for Spinal Implant Kit- Reverse engineering, identifying past design and drawbacks- Design modification based on implant application, calculation of torque and change in mechanism- 3D modeling on ProEngineer, CNC Programming Project successfully designed and is being sold by the company.CNC machining- CNC Programming for manufacturing of Grub Screw on Citizen and FANUC controllers- Involved in the design and CNC milling of silicon molding for the packaging of surgical kits Show less

Design and Assembly of Clocks used as promotional items for the company. The aim was to showcase their product of external fixator. The carbon fiber rings used in the fixator were chosen as basis of the design. The project involved:- Design and assembly of the components (screws, bolts and mounting bracket) using ProEngineer 3D CAD- Selection and sourcing of material, clock movement- Assembly and packaging