Test Eng I 223740 20503005

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.

This engineering position will join a team of about 30 people (i.e. System V&V team, that belongs to R&D department) and requires good technical skills to understand technical documentation in order to design and perform System V&V tests for products within the Renal Care Solutions business.

**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 with the references standards.
- Define the list of tests cases to be performed and the related sample size.
- Work closely with system team and developing team to design test descriptions and acceptability criteria.
- Perform product tests using, if necessary, 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.

**Qualifications**:

- Required: BS in Biomedical Engineering, in Computer Engineering, in Electronic Engineering or in Mechanical Engineering with minimum of 2 years of experience in product design V&V.
- Italian native speaker (preferred) or fluent Italian (Speaking, listening, and reading/writing).

**Skills required**:

- Demonstrated strength in building strong relationships at all levels of the organization, cross functionally, and with key people external to the organization.
- Knowledge of V&V processes.
- Knowledge of statistical tools to improve product and process understanding (Minitab, etc.).
- Familiarity with medical device regulatory environment including FDA regulations, MDR and IEC standards.
- Able to develop technical solutions to problems that require critical thinking.
- Must be team-oriented and able to guide the successful completion of major programs.
- Must be able to work with teams remotely and different geographical locations.
- Strong overall communication/presentation skills and technical writing skills.
- Able to work in global collaborating environment with intensive challenges.
- Fluent English (Speaking, listening, and reading/writing).

**Nice to have**:

- Previous work experience on dialysis devices.
- Previous work experience in testing laboratory environment (including experience of using measuring instruments of a laboratory).
- Knowledge of dialysis equipment reference standards (IEC 60601-2-39, IEC 60601-2-16 and collateral standards).

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.
It’s essential our team members feel valued, supported and empowered too. That’s why we provide a comprehensive total rewards package and opportunities to grow, develop and give back to the communities where we live and work - helping you reach your potential and enjoy a career full of life-changing possibilities.