Senior Validation / Design Transfer Specialist

Responsibilities:

  • Lead validation and verification activities (planning, execution, documentation) to ensure products meet design specifications and regulations.
  • Manage design transfer from development to manufacturing, ensuring a smooth transition and design integrity.
  • Collaborate with QA to develop and maintain quality systems compliant with industry standards (ISO, FDA).
  • Stay updated on regulatory requirements (particularly FDA PMA) and ensure compliance in all activities.
  • Work closely with R&D, manufacturing, and other departments to facilitate communication and project success.
  • Ensure thorough documentation of all validation and design transfer activities according to regulations and company standards.

Qualifications:

  • Bachelor’s degree in Engineering, Life Sciences, or related field.
  • Minimum 5 years of experience in validation and design transfer within the medical device industry.
  • Strong understanding of CE and FDA regulations and ISO standards for medical devices.
  • Proven experience with PMA approval processes a plus.
  • Excellent project management skills and ability to lead cross-functional teams.

Preferred Qualifications:

  • Advanced degree in a relevant field.
  • Experience with endovascular devices or similar medical device categories.
  • Familiarity with global regulatory standards and requirements.

To apply for this job email your details to jobs@insighthr.co.il

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