41037 Mirandola, Province of Modena, Italy Req #313
Monday, September 30, 2024
About Mozarc Medical At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology. Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies, Mozarc Medical offers an exciting and unique start-up experience backed by the support of two long-time industry and market leaders.
Driven by our mission and values, we put our patients at the center of all we do. Our employees play a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease. Find your purpose and passion at Mozarc Medical.
A Day in the Life This engineering position is part of a team of about 30 people and requires experienced technical skills and ability to understand technical documentation in order to design and perform V&V tests for products within the Renal Care Solutions business. The position is based in Mirandola, Italy.
Position Responsibilities: Create, implement and develop the product test plans/protocols and generate test reports to ensure product design meets the specifications and quality system requirements also in accordance to the references standards. Work closely with system team and developing team to design test descriptions and acceptability criteria. Perform product tests using laboratory tools (multimeter, oscilloscope, etc.). Perform statistical analysis of test results. Design test methods and perform test method validation activity, including MSA, writing the relative documentation. Provide test area with parameters for sample testing and specifies tests to be performed. Able to work in global collaborating environment with intensive challenges. Minimum Qualifications: Required: BS in Biomedical Engineering, in Computer Engineering, in Electronic Engineering or in Mechanical Engineering with minimum of 5 years of experience in product design V&V. Skills required: Advanced knowledge of statistical techniques and tools to improve product and process understanding (Capability Analysis, Design of Experiment, use of Minitab, etc.). Knowledge of tools for test system development, test automation and data analysis (LabVIEW, Matlab, Simulink, etc.) Familiarity with medical device regulatory environment including FDA regulations, MDR and IEC standards. Able to work independently and make improvements of products and processes. Must be able to work with teams remotely and different geographical locations. Nice to have: Previous work experience on dialysis devices. Previous work experience in testing laboratory environment. Knowledge of dialysis equipment reference standards (IEC 60601-2-16 and collateral standards). Design for Six Sigma (DRM/DFSS) Green Belt certified or equivalent. Able to develop technical solutions to problems that require critical thinking. Demonstrated strength in building strong relationships at all levels of the organization, cross functionally, and with key people external to the organization. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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