R&D Compliance Engineer

We are looking for a R&D Compliance Engineer who is passionate, detail-oriented, and collaborative to join us in our R&E Engineering team, based in our Mechelen office in Belgium or in our office in Malmö, Sweden.

You will be working in a team that ensures product compliance with relevant standards and Nipro's design and development process. This role is crucial in fostering a culture of design for compliance and quality, supporting continuous improvement, and ensuring the safety and regulatory compliance of our medical devices. You will collaborate with cross-functional teams to support the development of innovative and compliant medical devices that positively impact patient outcomes.

• University degree in Engineering, Quality Management, or related field.
• Team player mindset, coaching and supporting the team in best practices to achieve compliance.
• Experience in developing complex medical devices (class 2B/Class
  3) with embedded software.
• Experience in communication with notified bodies.
• Familiarity with quality techniques and statistical methods (e.g. Six Sigma).
• Experience with haemodialysis equipment and related technical standards (IEC 60601-2-16, ISO 23500, ISO 10993) is a strong plus.
• Familiarity with applicable Medical Device Cybersecurity regulations & standards is a plus.
• Expertise in design control, design change management, risk management, and product compliance.
• Maintain the Applied Standards List for haemodialysis machines, triggering possible Risk Management review in case of a detected change in the state of the art.
• Strong understanding of MDR requirements and IEC 60601-1 standards.
• Strong familiarity with ISO 13485, ISO 14971, IEC 62304 and IEC 62366 is an asset.
• Collaborate with cross-functional Nipro teams in EMEA and Japan, including R&D, Technical Service, QA, RA, Clinical and Marketing.
• Being able to speak Japanese is also a strong asset but not mandatory.