As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical Europe, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.”
To accommodate our growth we are looking for a System engineer, specialized in Dialysis systems.
About the Role
As System Engineer you lead the translation of user needs and product requirements into system design input and design output for hemodialysis equipment ensuring quality, compliance, regulatory, and stakeholder needs are met. This role requires strong technical skills, domain knowledge of dialysis systems, problem solving ability, co-ordination of stakeholders, and strong collaboration in the R&D team towards common project goals.
What You'll Do
- Develop and maintain system functional, process and design specifications & architecture in collaboration with other technical team members and external stakeholders
- Ensure traceability of user needs, design input, design output, verification, validation following the V-model
- Capturing design input from standards and risk control measures, with emphasis on essential performance, and ensuring proper verification is planned and executed
- Driving the design effort to create, define and document the design output, focusing on system architecture, and characterizing that the performance nominally conforms to the design input
- Ensure compliance to the product Applied Standards List and General Safety and Performance Requirements
- Supports proactive product impact assessments of new and updated product standards and regulations
- Contribute to innovation projects and initiatives with the identification and screening of unmet user needs followed by the ideation and screening of new concepts and technical solutions
- Work with Product Risk Management Owner in identifying, analyzing and managing risks according to ISO 14971 and the Nipro R&D QMS
- Support the planning & execution of formative and summative evaluations, managing usability risks in accordance with IEC 62366 and the Nipro R&D QMS
- Support verification & validation activities including test plan development and review, and review of test reports
- Provide technical expertise for feature prioritization and planning for product roadmaps in Product Planning Committee meetings
- Assessing impact of design changes and translating analysis into timelines and costs
- Support complaint investigations and post-market risk assessments & investigations as needed
- Collaborate with technical services as needed for documentation, product training, service tools, calibration process optimizations, service and life data analysis, etc
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 are a System Engineer with at leas 5 years of relevant experience
- You have a background in dialysis
- You are strong in planning and organizing
- You are a good communicator
- Expected experience with requirements management, system architecture, usability, risk management. Experience with system modelling (e.g. Matlab & Simulink) is highly desired
- You have an entrepreneurial mindset and are committed to challenging tasks
- You are result-oriented
- You are always eager to learn and develop yourself further
- Excellent command in English is required, additional languages are a plus
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.