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Design Assurance Engineer for Medical Devices

vor 1 Monat


Berlin, Berlin, Deutschland Novanta Vollzeit
Join Novanta's Team as a Design Assurance Engineer

At Novanta, we're shaping the future of healthcare and advanced manufacturing with innovative technology. As a Design Assurance Engineer, you'll play a crucial role in ensuring the quality and safety of our medical devices.

Key Responsibilities:
  • Develop and implement quality plans, including document control and verification and validation plans.
  • Review and approve design verification and validation test specifications for medical devices.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements, such as GDP, MDR 2017, and CFR 820.
  • Contribute to risk management and FMEA activities to identify and mitigate potential risks.
Requirements:
  • Completed technical or physical studies.
  • At least 2 years of professional experience in product quality in a highly regulated industry.
  • Experience with quality methods and techniques, including risk management and FMEA.
  • Excellent communication and teamwork skills.
  • English language skills (B2) required.

Novanta is an equal employment opportunity and affirmative action workplace. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.