Design Assurance Engineer

Novanta

Brno, Czech Republic
Hybrid
Design control according to gdp, mdr
Risk management according to iso 14971
Fmea analysis
As a Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (electronic devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development

Job Summary

  • As a Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (electronic devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development.
  • Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific.
  • Benefits include an extra week of vacation, 5 sick days, Flexi Pass vouchers, contribution to supplementary pension insurance, and flexible working hours.

Matching Summary

As a Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (electronic devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development.

Skills & Requirements

Must-have

  • Design Control according to GDP, MDR
  • Risk management according to ISO 14971
  • FMEA analysis
  • Product quality in regulated industry
  • Design verification and validation

Nice-to-have

  • Teamwork and collaboration
  • Quality-conscious and reliable
  • Structured and systematic approach
  • Willingness to travel

Key Requirements

  • Completed engineering studies
  • At least 2 years of professional experience
  • English language skills required (B2)

Work Rights

Not specified

Tailored Resume

Cover Letter