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Design Assurance Engineer

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Bussolengo, Veneto, Italia Orthofix A tempo pieno
Job Summary

We are seeking a highly skilled Design Assurance Engineer to join our Quality & Regulatory Department at Orthofix. The successful candidate will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Collaborate with cross-functional teams to develop and implement design validation plans, protocols, and reports.
  • Coordinate and manage internal and external testing activities to ensure compliance with regulatory requirements.
  • Maintain and update existing validations to ensure ongoing compliance with international and regulatory standards.
  • Work closely with Regulatory Affairs to prepare and submit regulatory submissions.
  • Develop and maintain Technical File documentation for new products and product modifications.
  • Support the development of Summary Technical Documentation (STED) for regulatory purposes.
  • Contribute to the preparation and review of product technical and marketing sheets.
Requirements
  • Technical degree or Master's degree in Engineering with an electronic background.
  • 3 years of experience in a similar position in an implantable medical device company.
  • Excellent knowledge of technical standards, including ISO 10993 series, ISO 11607 series, ISO 11137 series, ASTM F1980, ANSI/AAMI ST79, and FDA Guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'.
  • Strong understanding of relevant regulations and international standards, including European MDD, MDR, FDA Guidances, ISO 13485, and ISO 14971.
  • Fluent English language skills, both written and oral.
  • Very good knowledge and ability to use standard office applications.