Senior Test Engineer

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.

Location: Mirandola (MO) – ITALY