Senior Medical Device Engineer

4 days ago


Jamnagar, Gujarat, India beBeeRiskAssessment Full time ₹ 15,00,000 - ₹ 30,00,000

Medical Device Engineering Leadership Opportunity

We are seeking a highly skilled and experienced Medical Device Engineer to lead our team in assessing and auditing medical devices. This individual will be responsible for ensuring compliance with international standards.

Main Responsibilities:

  • Evaluate medical devices against ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their applications.
  • Apply risk management principles as per EN ISO 14971 and possess solid knowledge of non-active devices.
  • Collaborate with a team of assessors/auditors on sterilization processes.

Necessary Qualifications:

  • Minimum 10 years of experience in healthcare products or related fields.
  • A minimum of 5 years of experience in quality management is required.

Required Skills:

  • Good understanding of regulatory affairs and quality management principles.
  • Ability to analyze complex technical data and make informed decisions.
  • Excellent communication and interpersonal skills.


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