Design and development of high precision CNC machines

• Functioning as a key member in New Product Development team (NPD) in order to design and develop medical devices that meets user requirements. • Created Design control documents, product 3D models, 2D drawings for pats & assembly & Bill of Materials (BOMs). • Worked on deliverables such as Risk management documents, Design verification & Validation, Trace matrix, unique device identification (UDI) and Packaging.• Strong understanding of medical device standards, guidelines and regulation per ISO 13485, ISO 14971 and US FDA 21 CFR Part 820. • Performed engineering changes through proper planning & analysis of change impact, creation of change orders/notices and applicable documents, execution of change for implementation through multiple review process & coordinating with various stakeholders involved. • Performed Tolerance stack-up analysis, GD&T, case-fit check and Strength analysis as required. • Worked on technical Gap Analysis & Remediation of Design History Files of medical devices in order to compliance with the European Medical Devices Regulation (MDR 2017/745). • Strong knowledge of engineering fundamentals and application of the same during concept generation or re-design of products.• Provide management with project status updates on assigned responsibilities and goals, and escalate issues in a timely fashion. • Providing mentoring and coaching to my team members. • Maintaining focus on client needs and expectations, follow up to ensure satisfaction and improve products and services.

• Responsible for Cross Functional Team in order to optimize and finalize the different steps of machining operations of a new part. • Successful in doing functions such as Process planning, Inspection methods, Supplier availability, Delivery schedules to development parts.• Preparing Process flow, Inspection methods, Control plan and defining timeline for all development parts.• Fixtures concept generation with respective team with mistake proofing to have better holding of a part during machining process.• Drafting a part with GD&T to create drawings with respect to number of sequences involved in machining operation.• Generating PPAP documents for development parts based on customer requirements.

• Responsible for Process planning, Inspection methods, ensuring vendor availability for Gear Manufacturing for ancillary parts to the machines like Textile machines & Special purpose machines. • Machining process generation for new parts in order to achieve low number of sequences in machining. • Creating Process Flow Chart and Inspection check sheets with respect to number of operations involved • Worked on Program creation for CNC Turning center. • Inspecting part to meet out the customer requirement and creating product layout in order to achieve less man and material movement.