Senior Manufacturing Engineer

Senior Manufacturing Engineer Introduction about us At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—"Creating a future worth living. For patients. Worldwide. Every day."—we work with purpose and compassion, supported by a global team of over 125,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work: - We Care for our patients, each other, and our communities - We Connect across teams and borders to deliver excellence together - We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation Information about Engineering Department The Buzen Plant of Fresenius Medical Care is a key manufacturing site in Japan, producing high-quality medical devices and dialysis-related products. Operating under strict GMP and QMS standards, the plant ensures product safety, reliability, and compliance while supporting both domestic and global healthcare needs. The Engineering Department plays a vital role in maintaining stable and efficient operations by managing production equipment, utilities, and infrastructure, and by driving maintenance strategies, equipment improvements, and safety compliance. Engineering collaborates closely with production, quality, and other cross-functional teams, while also coordinating with external vendors and the Inukai Plant to ensure consistency and operational excellence across sites. Summary about role As a Senior Manufacturing Engineer, you will be responsible for ensuring the stable operation and continuous improvement of manufacturing equipment, utilities, and facility systems. The role contributes to production reliability, cost optimization, and compliance with GMP/QMS and safety standards through maintenance planning, equipment upgrades, and energy management initiatives. You will also provide technical leadership, drive problem-solving activities, and support the development of junior engineers while collaborating with internal and external stakeholders. Key Responsibilities 1. Equipment Maintenance & Reliability - Plan and execute maintenance strategies - Perform preventive maintenance - Monitor equipment performance and respond to failures 2. Continuous Improvement & Engineering Projects - Lead equipment upgrades - Perform root cause analysis - Support validation and qualification 3. Compliance & Quality - Ensure GMP/QMS compliance - Follow SOPs and safety policies 4. Collaboration - Work with internal teams and external vendors 5. Energy & Cost Optimization - Monitor energy usage and reduce cost 6. Leadership - Train and mentor junior engineers Your Profile - Degree in Engineering - 3+ years manufacturing experience - GMP/QMS knowledge - Strong problem-solving skills - Good communication skills - Japanese (fluent), English (business level) Our Offer - Work in a global healthcare leader - Contribute to high-quality manufacturing - Career development opportunities - Collaborative work environment 会社紹介(Introduction about us) フレゼニウス メディカル ケアは、腎臓ケアのグローバルリーダーとして、慢性腎臓病患者の生活向上に貢献しています。当社は、医療のあらゆるプロセスにおいて高品質で革新的な製品・サービスを提供することを使命としています。 エンジニアリング部門について フレゼニウス メディカル ケア豊前工場は、日本における主要な製造拠点であり、高品質な医療機器および透析関連製品を製造しています。厳格なGMPおよびQMS基準のもとで運営されており、製品の安全性・信頼性・コンプライアンスを確保しつつ、国内およびグローバルの医療ニーズを支えています。 エンジニアリング部門は、生産設備、ユーティリティ、およびインフラの管理を通じて、安定かつ効率的な操業の維持において重要な役割を担っています。また、保全戦略の推進、設備改善、安全・コンプライアンスの確保に取り組んでいます。さらに、生産・品質などの関連部門と密接に連携するとともに、外部業者や犬飼工場とも協働し、拠点間の整合性およびオペレーショナルエクセレンスの実現に貢献しています。 職務概要 シニア マニュファクチャリングエンジニアは、製造設備、ユーティリティ、および施設関連設備の安定稼働と継続的改善の確保を担います。保全計画の立案・実行、設備更新、エネルギー管理の推進を通じて、生産の信頼性向上、コスト最適化、およびGMP/QMSや安全基準の遵守に貢献します。 また、技術的リーダーシップを発揮し、課題解決を推進するとともに、社内外の関係者と連携しながら若手エンジニアの育成を支援します。 主な業務内容 1. 設備保全と信頼性向上 ・設備保全計画の立案・実行 ・予防保全の実施 ・トラブル対応 2. 改善活動 ・設備改善・更新の推進 ・不具合の原因解析と再発防止 3. 品質・コンプライアンス ・GMP/QMS遵守 ・SOPに基づく業務遂行 4. 関係部門との連携 ・社内部門や外部業者との調整 5. エネルギー管理 ・エネルギー使用の最適化 6. 人材育成 ・後輩の指導・育成 応募資格 ・工学系学位または同等の知識 ・製造業でのエンジニア経験3年以上 ・GMP/QMSの知識 ・問題解決力、コミュニケーション力 ・日本語:ビジネスレベル(必須) ・英語:基礎〜ビジネスレベル 当社で働く魅力 ・グローバル企業でのキャリア形成 ・高品質な医療製品に貢献 ・成長機会と研修制度 ・チームワーク重視の職場 Creating a future worth living. For patients. Worldwide. Every day. Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients' quality of life by offering them high-quality products as well as innovative technologies and treatment concepts. Let's stay connected! Joining our talent network allows us to send you new job opportunities!