Senior Medical Device Engineer

6 days ago

Bellary, Karnataka, India beBeeMedicalDeviceEngineer Full time ₹ 15,00,000 - ₹ 25,00,000
Medtech R&D

The role of Medtech R&D involves designing and developing medical devices, including those related to mechanical, electrical, and software engineering.

Roles and Responsibilities:
  • Create a quality culture by driving compliance activities around specific products, sites, or regions.
  • Experience in Medical Device QMS processes.
  • Organize and lead successful QMS processes at a medical device facility.
  • Communicate complex messages and negotiate with others to adopt different perspectives.
  • Use high-level judgment to make decisions and handle complex tasks or problems that impact site compliance.
  • Ensure process compliance through the development of comprehensive procedures and documentation.
Required Qualifications:
  • Bachelor's Degree or higher in a relevant field.
  • Experience in establishing Design Quality Control, Assurance, Regulatory Affairs teams & competence development from scratch within a regulated industry.
  • Effective communication skills in English (both written and oral).
  • Understanding and interpretation of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc., for Class 2 and Class 3 devices.

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