Senior Device Engineer

19 hours ago

Kanpur, Uttar Pradesh, India beBeeMedicalDevices Full time ₹ 18,00,000 - ₹ 25,00,000
Medical Devices Specialist

We are seeking a highly skilled Medical Devices Specialist to join our team. As a key member of our engineering department, you will be responsible for ensuring the quality and safety of medical devices.

Main Responsibilities:
  • Lead a team of engineers in the development, testing, and certification of medical devices.
  • Ensure compliance with regulatory standards such as ISO 13485 and MDD 93/42/EEC.
  • Develop and implement risk management strategies using EN ISO 14971.
  • Collaborate with cross-functional teams to design, manufacture, and sterilize non-active devices.
Key Requirements:
  • 10+ years of experience in medical devices or related fields.
  • 5+ years of experience in quality management is essential.
  • Expertise in regulatory affairs, research and development, and manufacturing processes.
Preferred Qualifications:
  • Knowledge of MDR 2017/745 and MDSAP.
  • Experience working with teams of assessors and auditors.
  • Solid understanding of sterilization processes and non-active devices.
What We Offer:

You will have the opportunity to work on challenging projects, collaborate with a talented team, and contribute to the development of innovative medical devices.

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