Lifecycle Engineering Manager

About The Company

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.

About The Company

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.

About The Role

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

How You Will Contribute

• 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.

Time spent

• Feature Investigations & Requirements Development: 20%
• Test Engineering Technical Leadership: 20%
• Design Control, Documentation & Traceability: 10%
• Change Control Leadership: 15%
• Quality Investigation & Field Support: 15%
• People Management & Team Development: 15%
• Vision & Strategic Direction for Mechelen R&D: 5%

What You Bring To Nipro

• 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.
• Systems Engineering & requirements development.
• 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.

Considered as an asset:

• 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).
• Risk Management (ISO 14971).
• 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).
• Japanese or European design partner experience.
• Japanese language proficiency.
• Coaching/mentoring certification.
• Agile or Lean in regulated hardware.
• ISTQB certification.
• Statistics/reliability (Six Sigma, DOE, FMEA, Weibull).

Why you should apply

• 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 exp