Design Assurance Engineer Medical Devices (m/f/d)
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.
As 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 (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. Within the framework of design control:
- Support on creation of overall superior quality plan including document plan and overall VnV plan
- Review of design verification and validation test specification for medical devices (equipment and consumables)
- Review of design control documents according to GLP, GDP, CFR820
- Member of the product and design FMEA team As a member of the risk management team according to ISO 14971:
- Contribute to the content of the risk management throughout the product development
- Review of the systematics and completeness of the risk analysis
- Evaluation of risk-reducing measures regarding impact on severity of damage and probability of occurrence
- Creation and review of the evidence for implementation and effectiveness of the measures In cooperation with Quality Assurance and Production:
- Involvement in the preparation of test specifications and test requirements for the series testing of medical devices Other tasks:
- Active participation in measures for synchronization and improvement of processes
- Failure analysis for field returns and during development
- Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions by quality/environmental officers and the specialist for occupational safety
- 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 fluency, Germany would be plus
- Quality-conscious, trustworthy and reliable
- Team player
- Good communication skills
- Structured and systematic way of working Travel Requirements
Willingness to travel to all locations and business contacts (10%)
We offer
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