Aktuelle Jobs im Zusammenhang mit Design Assurance Engineer for Medical Devices - Berlin, Berlin - Novanta
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Design Assurance Engineer for Medical Devices
vor 1 Monat
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 Team
As a Design Assurance Engineer, you will be 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.
Key Responsibilities
- 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
Additional Responsibilities
- 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
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.
