Device Engineer Lead

2 weeks ago


Kurnool, Andhra Pradesh, India beBeedevice Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Device Engineering Role

We are seeking a seasoned Device Engineer to lead our medical devices assessment and auditing initiatives.

About the Job:

  • This is an excellent opportunity for a highly experienced professional in the healthcare products industry, with a focus on quality management, regulatory affairs, and risk assessment.

Key Responsibilities:

  • Develop and implement robust quality management systems to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and other relevant standards.
  • Collaborate with cross-functional teams to assess and mitigate risks associated with medical device development, manufacturing, and deployment.
  • Provide expert guidance on regulatory requirements, including MDR 2017/745, MDSAP, and IMDR.

Requirements:

  • At least 10 years of experience in the healthcare products industry, with a strong background in quality management and regulatory affairs.
  • Proven expertise in risk management, including EN ISO 14971.
  • Familiarity with sterilization processes and non-active devices.

What We Offer:

  • A dynamic work environment with opportunities for growth and professional development.
  • Collaboration with experienced professionals in the medical devices sector.


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