Vishnu Suresh

• Conducts studies and makes recommendations for purchase and implementation of new technologies, practices, tools, and equipment to maximize site effectiveness.
• Ensures that process, equipment, and product designs are compliant with all Company policies and procedures as well as regulations.
• Takes initiative and demonstrates inquisitive approaches to solve moderately complex problems, identifying problems, generating alternatives, and recommending solutions.
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• Knowledge in Design documentation processes, DHF Remediation, Technical File Remediation.
• Good hands on experience in Medical Devices, ISO 13485 process, ISO 14971 Risk Management, FMEAs, Protocols, Report and Data drafting etc.
• Hands on work experience in FMEAs (Design/Process/Use) and Remediation.
• Knowledge on Trace Matrix for Design Input and Design Output with V&V traces.
• Work with Quality, Regulatory and other cross function teams to clear documents for review.
• Knowledge on design verification and validation (Protocol and final report preparation)
• Handle Design Verification,Design Validation and related technical documentation.
• Worked within applicable standards, policies and regulatory guidelines to promote safe working environment.

• Review product design for compliance with engineering principles, company
  standards, customer contract requirements, and related specifications.
• Apply knowledge of APQP & FMEA to ensure quality products are designed at the first time and prevent identified issues from recurring.
• Ensure smooth transition of products from early stage sampling to high volume production on time and with quality and cost expectations of company.
• Interface with all relevant departments from R&D through sales and marketing to ensure product offering meet time and cost deadlines.

• Responsible for operating computer aided design (CAD) systems and peripheral
  equipment to convert engineers and technicians designs into working computer
  documents.
• Handle task of reviewing work order and procedure manuals to determine
  critical dimensions of design.
• Perform calculation for purpose of converting design dimensions to feasible
  dimensions for subsequent production processes.
• Research, design, evaluate, install, operate, and maintain mechanical products,
  equipment, systems processes to meet requirements, applying knowledge of
  engineering principles.

First Class - 67.22%

K.M.C.T College of Engineering, Calicut

University of Calicut

First Class with Honors - 82.38%

Sun Institute of Technology, Nagercoil, TamilNadu

Department of Technical Education (DOTE), Tamilnadu

First Class - 73%

St.Michael's H.S.S, Kaduthuruthy

Board of Higher Secondary Examination, Kerala

First Class - 66.5%

St: Aloysius H.S.S, Athirampuzha

General Education Department, Kerala