Experience

• 

  Khonsu llc

  Jan 2016 - Dec 2017

  Design engineer

  • Designed and development of Mechanical Foot Ratchet that works on collapsible pole system that builds inflexible tent pole using in SOLIDWORKS and CREO Parametric 2.0 • Responsible for the manufacturing of hiking and backpacking tent• Involved in design of hiking and medical tent• Ensured that Quality Assurance standards, as well as Design Controls have been adequately implemented to ensure that anticipated products and product changes are clearly defined and documented and that resulting design objectives are met throughout the product life cycle Show less

• 

  Depuy synthes

  Apr 2018 - now

  • Provided project execution plans involving Product development and design aspects of a project, participating in cross-functional project teams through all phases of the product development process within portfolio optimization projects.• Lead executioner in drawing updates activities, adding NB number and 2D barcoding on parts using Unigraphics and routed in ADAPTIV, WINDCHILL and TEAMCENTER.• Modified and maintained a Bill of materials using labelling stock, IFU components, packaging phantom, drawings, and Authorized representative labels.• Coordinated with an outside supplier to get supplier-owned drawings done.• Created new 2D data matrix Work instructions for DePuy Spine and MiTek to maintain product compliance with ISO/MDR standards.• Assigned GMDN, classification, and grouping for starting Tech file execution.• Created Key Functional elements for DePuy Spine Instruments, implants and cases and trays and caddies per the latest EU MDR regulations.• Led cross-functional team in Creating a new label, revising Class I IFUs, and drawings for CE removal from parts.• Updated all R&D/Quality documentation (e.g., Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) for DePuy Spine products in line with the General Safety and performance requirements specified within the MDR legislation in line with new product groupings.• Drafted 2 technical files and reviewed at least 6 technical files per EU MDR regulations.• Involved in sustaining engineering activities such as the creation and review of design change evaluation, change order routing, approval, and release of drawing prints• Revised Sterile and non-sterile package drawings for concurrent manufacturing.• Led the Regulatory team to find and remove promotional, clinical, and marketing claims from technical documentation such as Surgical technique guides, IFUs, IOVV, Clinical evaluation and promotional sites. Show less Marketing and RA• Update STG and IFU• Claims - Surgical Technique Guide, Performance, clinical, marketing• Create and develops Key Functional Elements• Update Bridge Document, Patient Implant Card, PIL R&D• DFMEA, IOVV, SCL, RMP, RMR, traceability matrix, Verification and Val Summary• Interaction with cross functional team to track the deliverables from various teams such as, manufacturing, design quality, medical and regulatory affairs on design change requests in orders to ensure the assignment is moving towards the goal• Disassembly InstructionsPackaging• Worst Case (Cases and Trays, update and create sterile package drawings• Create Poly bags models and Sketches as per DePuy Standards Bio-Comp• Patient Contact (Direct, Indirect, Tissue, Bone, Blood)• Bio-comp Report (Sections I and II) and Rationale • Select Worst Case part for Bio-comp testing - Supplier Wise (Cleaning Validations, PVE, PVA, Surface Area, thk.)PLM - Create change assessment and route change orders in ADAPTIV, Teamcenter, Windchill Show less

  • Senior Project Engineer

    Jan 2025 - now

  • Senior R&D Engineer

    Mar 2022 - now

  • Product Development Engineer

    Dec 2018 - Mar 2022

  • Validation Engineer

    Apr 2018 - Dec 2018