Software Engineer Japan Jobs in Wisconsin (NOW HIRING)

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 38,000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical EMEA, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.

For Nipro Europe Group Companies, we are looking for a Lifecycle Engineering Manager who is experienced, hands-on, and communicative to join us in our R&D team, based in our EMEA headquarters office in Mechelen, Belgium.

As Lifecycle Engineering Manager, you will lead and develop a team responsible for sustaining and evolving life‑saving dialysis products throughout their lifecycle. You will shape engineering processes, strengthen technical capabilities, and ensure high standards in testing, design control, traceability, and product compliance. Working closely with colleagues across Belgium, Sweden, Japan, and other international locations, you will help create innovative and reliable medical technologies that improve patient care worldwide

• Lead and develop a high‑performing lifecycle engineering team.
• Drive feature investigations and requirements development for product enhancements.
• Establish testing strategies ensuring product quality, reliability, and compliance.
• Own design control, traceability, and technical documentation processes.
• Support product changes, investigations, and field performance improvements.
• Collaborate globally to improve engineering practices and team capabilities.
• Feature Investigations & Requirements Development: 20%
• Test Engineering Technical Leadership: 20%
• Quality Investigation & Field Support: 15%
• People Management & Team Development: 15%
• Vision & Strategic Direction for Mechelen R&D: 5%

• Engineering degree in biomedical, mechanical, electrical, or related discipline.
• Extensive medical device R&D engineering experience within a regulated industry environment: ISO 13485, MDR,/FDA design control, IEC 60601, ISO 14971, Verification & Validation documentation for regulatory submissions.
• Test Engineering leadership.
• Proven people leadership and team development experience.
• Strong knowledge of design control and verification activities.
• Experience creating engineering processes and improving ways of working.
• Excellent communication and cross-functional collaboration skills.

• Dialysis or renal therapy domain knowledge & IEC 60601216 familiarity.
• Test automation (software test frameworks/CI, hardware test benches using e.g.
• Usability engineering (IEC 62366, formative/summative validation).
• Biocompatibility testing (ISO 10993 experience).
• MDR Technical File or FDA 510(k) submission experience.
• MBD and/or MBSE experience.
• Sustaining engineering: field investigations, post-market surveillance, change control.
• Change control board experience (change owner or CCB participant).
• Multi-site organization experience (geographic coordination, remote teams).
• Coaching/mentoring certification.
• Agile or Lean in regulated hardware.
• ISTQB certification.
• Statistics/reliability (Six Sigma, DOE, FMEA, Weibull).

At Nipro, you will join an organisation with a clear purpose: improving patient lives through innovative healthcare solutions. You will be working in a team that values expertise, collaboration, continuous learning, and mutual support.

This is an opportunity to make a visible impact by shaping the future of lifecycle engineering within a growing international medical technology organisation. You will have the autonomy to build team capabilities, improve engineering excellence, and influence how products are developed and sustained.

You will collaborate with talented colleagues across Belgium, Sweden, Japan, and other global locations, giving you exposure to diverse perspectives and complex technical challenges.

• A meaningful role supporting technologies that improve patient outcomes.
• Opportunities to lead, mentor, and grow a skilled engineering team.
• A collaborative international environment with strong cross-functional partnerships.
• A very multicultural work environment with more than 39 different nationalities within our regional HQ.
• A culture focused on continuous improvement, innovation, and quality.
• The chance to influence the future direction of engineering capabilities and processes.

Our purpose is grounded in care, respect, and a deep commitment to the well‑being of every life we touch—patients, partners, and team members. We believe that every colleague at NIPRO plays a vital role in our mission: to push innovation forward, improve patient outcomes, and make world‑class healthcare accessible to all.

Respect is active and essential at NIPRO - it is our way of working, thinking, and growing together. We promote an environment where people feel safe to contribute, constructive ideas flow freely, and every person is treated with dignity.