Ashish Gowda Hm

About Ashish Gowda Hm

I\'ve given a highlights here, for more details please ask me for my RESUME.I\'m a Senior Mechanical Engineer familiar with Design control of medical device design and development as per ISO 13485. I\'m proficient in each aspect of Medical Device design control since I\'ve worked in each phase - Conceptualisations, Design input, Design Output, Verification and Validation of new product designs with proper risk assessments from the knowledge on ISO 14971.I\'ve Worked on End to End design Transfer in new product development. Excellent Collaborator, worked with cross functional teams and rectified the conflicts with solution.My experience includes leading Value Analysis/Value Engineering (VAVE) and Remediation compliance projects for a diverse portfolio of medical devices, specifically focusing on Class IIb, Class Ir and Class Im Surgical instruments and Implants.Regarding current NPD project for a cardiovascular surgical machine, I manage the product from Conception to manufacturing readiness. My responsibilities include defining system architecture (SRS/concepts), cross-functional technical leadership, Creation and management of the complete Bill of Materials (EBOM/MBOM), cost estimation using the infinite costing method, and vendor validation. I essentially own the design output and its formal verification plan.A strong collaborator who effectively partners with cross-functional stakeholders—from FEA/CFD to Purchase, manufacturing vendors, Electrical, Finance, Operations and supply chain —to ensure seamless communication and successful integration of design specifications.Expert at converting system teardown data into actionable VAVE targets using Excel spreadsheets.​I offer a balanced skill set in compliance, design, and cost optimization, having successfully performed MDD-to-MDR Gap Analysis, driven product improvements via VAVE and Benchmarking, and managed medical device design changes based on specific surgeon requests.Worked in sustenance projects focused on regulatory compliance, ensuring all legacy Drawing and Technical Documentation conformed to current standards and were released via Engineering Change Management (ECO/CR/CN) within the PLM system. Worked in Technical Documentation (including dFMEA, DHF, HDD, and KFE) and Quality Systems, including CAPA, Risk Management, Root Cause Analysis of PMSR and complaints, and ERP management for supply chain efficiency.Proficient in utilising Microsoft Excel.Excellent in Communication and Presentation skills.CAD Tools : Solidworks, NX.PLM: Adaptive, Windchill, Agile and Team Centre.

Experience

1. Senior Design Engineer

   Tata Elxsi

   Feb 2024 — Present · Bengaluru, IN

   I\'m a TATA ELXSIan

Education

• Malnad College of Engineering, HASSAN

  Bachelor of Engineering - BE, Mechanical Engineering

  2016 — 2020

• BRILLIANT PU COLLEGE

  PUC, Computer Science

• Gyaralli Thammaiah institution

  10th, SSLC