Design Assurance Specialist for Medical Devices and Systems

vor 3 Wochen


Berlin, Berlin, Deutschland Novanta Vollzeit

Transforming Healthcare and Manufacturing with Innovative Solutions

At Novanta, we empower our global customers with engineered components and sub-systems that deliver extreme precision and performance for mission-critical applications.

We are seeking a talented Design Assurance Engineer to join our team. As a key member of our product development team, you will be responsible for creating an overall quality plan, reviewing design verification and validation specifications, and leading/contributing to risk management, FMEA, and other quality-related tasks.

Key Responsibilities:

  • Support the creation of an overall superior quality plan including document plan and overall VnV plan
  • Review design verification and validation test specifications for medical devices (equipment and consumables)
  • Review design control documents according to GLP, GDP, and CFR820
  • Participate in the product and design FMEA team

Collaboration and Innovation:

  • Contribute to the content of the risk management throughout the product development
  • Review the systematic and completeness of the risk analysis
  • Evaluate risk-reducing measures regarding impact on severity of damage and probability of occurrence
  • Develop and review evidence for implementation and effectiveness of measures

Requirements:

  • Completed technical and/or physical studies
  • At least 2 years of professional experience
  • Experience with product quality in a highly regulated industry (medical device, automotive, aviation)
  • Experience in theory and application of quality methods and techniques
  • English language skills (B2) required
  • Quality-conscious, trustworthy, and reliable
  • Team player
  • Good communication skills
  • Structured and systematic way of working
  • Willingness to travel to all locations and business contacts (10%)


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