Technical Specialist for Medical Device Design Verification

5 giorni fa

Mirandola, Emilia-Romagna, Italia Cooper Machinery Services A tempo pieno

At Mozarc Medical, we're reimagining the future of holistic kidney health technology. We're driven by our mission and values, putting our patients at the center of all we do. Our team of engineers plays a key role in developing technology solutions that enrich patients' lives and create meaningful progress in the treatment of kidney disease.



Job Description

This engineering position is part of a team of around 10 people, requiring experienced technical skills and ability to plan, perform and document characterization and Design Verification testing for single use devices within the Renal Care Solution business. The position is based in Italy.



Responsibilities


  • Create and develop DVT Plan, Product Test Protocols and Reports documentation to ensure product design meets specifications and subsystem requirements also in accordance with the reference standards
  • Collaborate with developing team to define test purposes and acceptance criteria and perform characterization/feasibility testing
  • Execute Performance and Physical Testing using laboratory equipment (dynamometer, leak tester, manometer, etc.)
  • Statistical data analysis of test results
  • Develop Work Instructions for Test Methods and perform test method validation activities, including MSA; perform testing for validation and writing the relative documentation
  • Equipment Qualification and SW Tool Validation
  • Have a focus on objectives to meet the assignments and contribute to the achievement of projects goals
  • Work in a team and collaborate with different sites and disciplines (Design Quality, System, Regulatory, Human Factor teams)


Requirements


  • BS in Biomedical Engineering, Material Engineering, Chemical Engineering, Chemistry with minimum 4 years of experience in Medical Device product design, verification, validation
  • Familiarity with medical device regulatory environment including FDA regulations and MDR
  • Knowledge of statistical techniques and tools (use of Minitab, DOE, Statistical Sampling, etc.)
  • Ability to work in team and good collaboration attitude
  • Methodical, critical thinking and analytical approach to solve issues
  • Result-oriented attitude to the planned timelines
  • Good oral and written communication and interpersonal skills
  • Fluent English, oral and written


Why Work with Us?

Working here is highly rewarding – we have the privilege of helping kidney patients experience greater freedom, improved outcomes and a renewed passion for life. We provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work.

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