Design Assurance Expert

5 days ago


GondrecourtleChâteau, Grand Est, United States Ativa Medical Full time

At Ativa Medical, we are seeking a highly skilled Design Assurance Engineer to join our product development team. This key role will play a critical part in ensuring the quality and safety of our medical devices.

We are looking for an individual with 5+ years of experience in Design Assurance in the Life Sciences industry, preferably with a background in Mechanical Engineering or a related field. Your expertise in risk management, design verification planning and execution, supplier management, and material quality activities will be invaluable to our team.

Key Responsibilities:

  • Conduct risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.
  • Manage traceability of design requirements through risk mitigation and design verification.
  • Develop technical documentation, including design verification plans, procedures, test protocols, and reports.
  • Critical review of design and process documents and records.
  • Lead key equipment qualification efforts and supplier management activities.
  • Review and evaluate non-conforming materials and work with vendors to correct them.
  • Generate inspection procedures for incoming parts and on-site production.
  • Review manufacturing documentation for accuracy and clarity.
  • Contribute to process validation activities.

Requirements:

  • BS in Mechanical Engineering or a related field.
  • 5+ years of Design Assurance experience in the Life Sciences industry.
  • Proficient knowledge of ISO 13485 and ISO 14971 standards.
  • Excellent communication and problem-solving skills.
  • Ability to work effectively in a team environment.

What We Offer:

  • A competitive salary range of $90,000 - $120,000 per year.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • The opportunity to work on exciting medical device projects and contribute to the success of our company.


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