Design Assurance Engineer Medical Devices (m/f/d)

Design Assurance Engineer Medical Devices (m/f/d) page is loaded## Design Assurance Engineer Medical Devices (m/f/d)locations: Berlin, Germanytime type: Full timeposted on: Posted 2 Days Agojob requisition id: R **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.This position is part of Novanta’s Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine, WOM 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 **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.Primary ResponsibilitiesWithin 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 teamAs 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 measuresIn cooperation with Quality Assurance and Production:* Involvement in the preparation of test specifications and test requirements for the series testing of medical devicesOther 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**Required Experience, Education, Skills and Competencies*** 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%)#LI-UK1#BerlinNovanta 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 if you need a disability accommodation for any part of the employment process.**Solving complex challenges, delivering innovations that matter!** is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol "NOVT".
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