Device Development Lead

2 days ago


Thāne, Maharashtra, India beBeeQuality Full time ₹ 15,00,000 - ₹ 22,00,000
Senior Device Engineer

This role demands a highly skilled professional with 10 years of experience in healthcare products or related fields, preferably in the medical devices sector.

Key Responsibilities:
  • Quality Assurance:
    • Ensure adherence to ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
    • Manage risk according to EN ISO 14971.
  • Team Collaboration:
    • Work closely with a team of assessors/auditors.
  • Device Expertise:
    • Have in-depth knowledge of non-active devices and sterilization processes.
Requirements:
  • At least 5 years of quality management experience.
  • Strong understanding of medical device regulations.


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