Senior Test Engineer

Position Title: Senior Test Engineer  

A Day in the Life

This engineering position is part of a team of around 10 people and requires experienced technical skills and ability to plan, perform and document characterization and Design Verification Testing (DVT) for plastic disposable medical  single use devices within the Renal Care Solution business.

The position is based in Mirandola, Italy.

Position 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 with a focus on disposable products and plastic materials
• 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)

Qualifications

BS in Biomedical Engineering, Material Engineering, Chemical Engineering, Chemistry with minimum 4 years of experience in Disposable Medical Device product design, verification, validation

Skills Required

• Familiarity with medical device regulatory environment including FDA regulations and MDR
• Knowledge of statistical techniques and tools (use of Minitab, DOE, Statistical Sampling, etc.)
• Fluent English, oral and written
• Ability to work in team and good collaboration attitude
• Able to work effectively with others on cross-functional and global teams
• Methodical, critical thinking and analytical approach to solve issues
• Ability to work independently with general supervision
• Good oral and written communication and interpersonal skills
• Result-oriented attitude to the planned timelines

Nice to Have

• Previous experience in verification and validation of medical device, preferably in the field of with dialysis single use devices (Peritoneal Dialysis) and plastic disposable products
• Previous experience with combo-product
• Previous work experience in testing laboratory environment
• Experience with submission of products to FDA
• Knowledge of reference standards (ISO 80369-1/7/20, ISO 8536-4/8/10, ISO 11607-1/2, ISO 15747)

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.