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Design Assurance Engineer for Medical Devices

vor 2 Monaten


Berlin, Berlin, Deutschland Novanta Vollzeit

Transforming Healthcare and Advanced Manufacturing

At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people's lives and redefining what's possible. We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Join Our Global Team

We are a global team with over 26 offices located in various regions. Our culture is built on teamwork, collaboration, and empowerment. We are looking for talented individuals to join our team.

Key Responsibilities

As a Design Assurance Engineer, you will be responsible for:

  • Creating an overall quality plan, including document plans and overall VnV plans
  • Reviewing design verification and validation test specifications for medical devices (equipment and consumables)
  • Reviewing design control documents according to GLP, GDP, CFR820
  • Participating in product and design FMEA teams

Risk Management and Quality Assurance

You will 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, and create and review evidence for implementation and effectiveness of the measures.

Collaboration and Communication

You will work closely with Quality Assurance and Production teams to prepare test specifications and test requirements for series testing of medical devices.

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, etc.)
  • 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%)

Equal Employment Opportunity

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