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About the Role
As a Design Assurance Engineer, you will be responsible for creating quality plans, reviewing design verification and validation specifications, and leading risk management activities for medical devices. You will ensure compliance with GDP, MDR, and CFR820 standards, contributing to the innovation and development of minimally invasive medical technologies.
Responsibilities
- Support the creation of a superior quality plan, including document and overall VnV plans.
- Review design verification and validation test specifications for medical devices (equipment and consumables).
- Review design control documents according to GLP, GDP, and CFR820.
- Act as a member of the product and design FMEA team.
- Contribute to risk management throughout product development according to ISO 14971.
- Review the systematics and completeness of risk analysis.
- Evaluate risk-reducing measures and their impact on severity of damage and probability of occurrence.
- Create and review evidence for the implementation and effectiveness of risk-reducing measures.
- Participate in the preparation of test specifications and test requirements for series testing of medical devices.
- Actively participate in measures for synchronization and improvement of processes.
- Conduct failure analysis for field returns and during development.
- Strictly comply with quality, occupational safety, and environmental regulations.
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 the theory and application of quality methods and techniques.
- Eligible to work legally in Germany.
- Willingness to travel to all locations and business contacts (10%).
Skills
- Quality planning
- Design verification and validation
- Risk management
- FMEA
- ISO 14971
- GLP
- GDP
- CFR820
- MDR
- English fluency
- German language skills (plus)
- Quality-conscious
- Trustworthy
- Reliable
- Team player
- Good communication skills
- Structured and systematic way of working
Location
- Berlin
Work Type
- Hybrid
Experience Level
- 2+ years
Education Level
- Technical and/or physical studies
Benefits
- Health services
- Financial services
About the Company
- Novanta's innovations power technology products transforming healthcare and advanced manufacturing.
- We create engineered components and sub-systems for mission-critical applications.
- Novanta operates globally with over 26 offices in The Americas, Europe, and Asia-Pacific.
- We foster a culture that embraces teamwork, collaboration, and empowerment.
- This position is part of Novanta’s Advanced Surgery business unit, specializing in Minimally Invasive Medicine.
- WOM develops devices and accessories for minimally invasive surgery, including cameras, insufflators, medical pumps, and tubing.
Equal 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.
- Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.