Design Assurance Engineer
External
Novanta · BrnoPrepare for this interview
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About the role
This position is part of Novanta's Advanced Surgery business unit . Specialized in the field of Minimally Invasive Medicine, this BU develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate. 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.
Responsibilities
- 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
- Your Experience, Education, and Skills
- Completed engineering studies
- At least 2 years of professional experience
- Experience with product quality in a highly regulated industry (medical device preferred, or automotive, aviation etc.)
- Experience in theory and application of quality methods and techniques
- English language skills required (B2)
- Quality-conscious, trustworthy and reliable
- Team player
- Good communication skills
- Structured and systematic way of working
- Willingness to travel to Berlin (10%)
Benefits
Additional Information
Build a career powered by innovations that matter! 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. Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.
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