Nipro Europe Group Companies is part of Nipro Corporation Japan, a leading global healthcare company with over 33.000 employees worldwide. Its European headquarters in Mechelen is home to Nipro Medical Europe, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium - a fully equipped research and training facility for medical professionals and Nipro employees alike. The geographical scope includes Europe, Africa, the Americas, and India.
To accommodate our growth, we are looking for a dynamic, hands-on System Verification Engineer at Nipro Europe Group Companies (NEGC).
About the role
As System Verification Engineer you take a leading role in planning, preparing, executing and documenting verification, validation and usability tests during the development of new dialysis equipment. This will involve writing test plans & procedures, having them reviewed and approved, executing tests, and recording the results following good documentation practice. This will require practical laboratory work and a technical background that enables you to have a solid understanding of the dialysis systems.
What you’ll do
- Lead the creation of Verification processes to support compliance with regulatory requirements related to data integrity and good documentation practice
- Lead and execute Verification & Validation activities, including writing test plans to verify design specifications and reviewing / approving test results that may be included in the product Design History File.
- Document, manage and maintain test records consistent with formal verification processes and Quality Management System policies and procedures.
- Support failure mode analysis and root cause investigations and contribute to developing technical solutions.
- Co-ordinate the logistics of sending dialysis equipment to external laboratories for external test activities.
- Design test cases to include test methodology, test setups, materials, procedures, requirements and acceptance criteria.
- Applying knowledge of Verification & Validation to scout for and support the implementation of new verification tools and processes
- Planning, coordination & execution of usability studies for dialysis equipment to support compliance with applicable standards (IEC 62366 and ISO 14971)
- Reviewing user needs, translation of needs into measurable specifications
- Able to collect, structure and organize data from end users
- Analyze objective and subjective data from usability studies to inform design and provide alternative solutions
- Able to communicate results from usability studies with internal and external stakeholders
- The employee performs all tasks in accordance with ISO quality and JSOX requirements, whilst always taking Nipro values into account
What You’ll Need
- You have a Bachelors or Masters degree in Electrical or Mechanical Engineering.
- Able to work independently given direction
- Able to perform practical, technical laboratory work as required
- 5 years of experience working in a similar role in class IIB medical device system verification
- Prior experience with dialysis machines is a big advantage
- Experience with designing or specifying custom test benches, measurement test setups and instrumentation is highly beneficial
- You have solid planning and time management skills
- You are a fluent in English (additional languages are a plus)
- Good communication and collaboration skills in a multi-cultural setting
- Attention to detail in specifying and documenting tests, following good documentation practice
- Flexibility to occasionally travel within Europe to support testing activities at external partners and notified bodies
What We’ll Offer
To the right candidate, we will offer the ability to develop and grow in a fast-paced international business setting. In addition to a competitive salary and benefits package, you will land in a friendly and dynamic workplace environment where people enjoy autonomy and taking initiative. Together with you and the team, you will be part of a “Nipro family network” that draws upon talent from around the globe.
Interested?
You can simply apply by clicking the Apply Now button.
