Senior Technical Lead for Medical Devices

5 days ago


Gulbarga, Karnataka, India beBeeEngineering Full time ₹ 20,00,000 - ₹ 25,00,000

Job Description

We are seeking an experienced Senior Device Engineer to lead our medical device initiatives. The ideal candidate will have a strong background in medical device development, quality management, and regulatory compliance.

Key Responsibilities:

  • Assess and audit medical devices to ensure compliance with relevant regulations.
  • Collaborate with cross-functional teams to achieve project goals.
  • Develop and implement quality management systems to meet regulatory requirements.
  • Conduct risk management assessments using EN ISO 14971.

Requirements:

  • At least 10 years of experience in the medical devices industry, including research and development, manufacturing, quality management, or regulatory affairs.
  • 5+ years of experience in quality management is essential.
  • Strong knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their application.
  • Experience with MDR 2017/745, MDSAP, and IMDR is highly desirable.

Benefits:

The successful candidate will have the opportunity to work on high-profile medical device projects, develop their skills and expertise, and contribute to the growth and success of our organization.

What We Offer:

  • A dynamic and supportive work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.


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