High-Tech Device Expertise Wanted

18 hours ago

Ghaziabad, Uttar Pradesh, India beBeeDevice Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Senior Device Engineer Job Overview

We are seeking an experienced professional to fill the role of Senior Device Engineer. The ideal candidate will have a strong background in medical devices, quality management, and regulatory affairs.

Main Responsibilities:

  • Conduct thorough assessments and audits of medical devices to ensure compliance with regulations such as ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Develop and implement effective risk management strategies using EN ISO 14971.
  • Collaborate with a team of assessors/auditors to achieve project goals.

Key Requirements:

  • At least 10 years of experience in the medical devices industry or related field.
  • More than 5 years of experience in quality management.
  • Strong knowledge of non-active devices and sterilization processes.

The successful candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
A key component of this role is ensuring compliance with relevant regulations, including ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.

Educational Background:

  • Bachelor's degree in engineering, biotechnology, or a related field.

Professional Qualifications:

  • PMP certification preferred but not required.

Skillset:

  • Effective leadership and collaboration skills.
  • Excellent written and verbal communication skills.
  • Ability to work under pressure and meet deadlines.

This role requires the candidate to be well-versed in regulatory requirements and able to communicate complex ideas effectively to both technical and non-technical stakeholders.

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