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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Lifecycle Engineering Manager - **Company:** Nipro Europe Group Companies - **Location:** Mechelen, Belgium - **Contract:** Permanent contract - **Skills:** Testing (Software), Agile Methodology, Systems Engineering, Automation of Tests, Failure Mode Effects Analysis, LabVIEW, Simulink, Strategies of Testing, Hardware Testing - **Published:** July 30, 2026 - **Apply:** https://be.indeed.com/viewjob?jk=b69eb058c8855308 ## About the Role * 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. * LabVIEW/Simulink, data acquisition systems) * Usability engineering IEC 62366, formative/summative validation) * Biocompatibility testing ISO 10993 experience) * Risk Management * 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 profeciency * Coaching/mentoring certification * Agile or Lean in regulated hardware * ISTQB certification * Statistics/reliability Six Sigma, DOE, FMEA, Weibull) ## Description 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% ## Related Videos - [Building a hypercar from scratch](https://www.wearedevelopers.com/videos/607-building-a-hypercar-from-scratch) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [WeAreDevelopers LIVE - Modern DevOps for IoT Devices and More](https://www.wearedevelopers.com/videos/1805-wearedevelopers-live-modern-devops-for-iot-devices-and-more) - [Agile work at CARIAD – Creating a customer web application for controlling the vehicle ](https://www.wearedevelopers.com/videos/200-agile-work-at-cariad-creating-a-customer-web-application-for-controlling-the-vehicle) - [Fake or News: Coding on a Phone, Emotional Support Toasters, ChatGPT Weddings and more - Anselm Hannemann](https://www.wearedevelopers.com/videos/1790-fake-or-news-coding-on-a-phone-emotional-support-toasters-chatgpt-weddings-and-more-anselm-hannemann) - [Model Based Systems Engineering in an Agile Product Development Process](https://www.wearedevelopers.com/videos/68-model-based-systems-engineering-in-an-agile-product-development-process) ## Related Articles - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [What is Software Engineering?](https://www.wearedevelopers.com/magazine/289-what-is-software-engineering) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Best Companies in the Netherlands: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/193-best-companies-in-the-netherlands-top-25-companies-in-2023) - [What’s the Difference between a Junior, Mid, and Senior Developer?](https://www.wearedevelopers.com/magazine/238-what-s-the-difference-between-a-junior-mid-and-senior-developer)