Chief Biomedical Equipment Designer

2 days ago

Pune, Maharashtra, India beBeeBiomedical Full time ₹ 15,00,000 - ₹ 20,00,000
Biomedical Engineer - Medical Device Development

Lead the development of medical devices and equipment, ensuring compliance with regulatory standards, safety requirements, and usability guidelines.

Design and develop medical devices and equipment, ensuring compliance with regulatory standards, safety requirements, and usability guidelines.

  • Develop detailed specifications for medical devices and equipment, conducting feasibility studies, and overseeing prototype fabrication and testing.
  • Manage the entire product development lifecycle, including setting project milestones, allocating resources, coordinating cross-functional teams, and ensuring timely delivery of high-quality solutions.
  • Monitor project progress, identify risks, and implement effective mitigation strategies.
  • Possess in-depth knowledge of biomedical engineering principles and practices, including electronics, instrumentation, mechanics, and materials science.
  • Stay up to date with the latest advancements in medical technology and contribute to research and development efforts.
  • Ensure compliance with applicable regulatory standards and guidelines, such as FDA regulations and international quality standards (e.g., ISO 13485).
  • Prepare and maintain technical documentation, including design files, risk management files, and regulatory submissions.
  • Develop and implement quality assurance procedures to ensure the safety, reliability, and performance of medical devices.
  • Collaborate with cross-functional teams, including physicians, nurses, scientists, and other engineers, to understand their requirements and incorporate their feedback into the design process.

Requirements:

  • Bachelor's or Master's degree in Biomedical Engineering or a related field (PhD may be preferred for certain positions).
  • Extensive experience (typically 8+ years) in biomedical engineering, medical device development, or a related field.
  • Strong knowledge of medical device regulations and standards (e.g., FDA, ISO).
  • Proficiency in engineering design software and tools (CAD, MATLAB, etc).
  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills.
  • Ability to work effectively in multidisciplinary teams.

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