Quest Global

Engineering services, digital transformation, asset management

Mechanical Engineer - working on consumables

Design EngineeringUpdated on Nov 7

Full-timeHigashimurayama, Tokyo, JapanNo salary listedIn-person

About the Job

Requirements

The candidate must be a native Japanese-speaking engineer and be younger than 40.
The candidate must communicate effectively in English with offshore teams.
The candidate must have project management experience.
The candidate must be skilled in 3D CAD modeling and mechanical architecture.
The candidate must be able to develop 3D CAD models of mechanical components, casting parts, and structural frames for a dialysis machine platform.
The candidate must be able to create high-precision 2D manufacturing drawings with geometric dimensioning and tolerancing (GD&T).
The candidate must be capable of integrating internal hardware, including blood pumps, arterial and venous clamps, and ultrafiltration modules, into a machine layout.
The candidate must have skills in plastic medical-device design, including disposable components and fluid dynamics optimization.
The candidate must be able to design plastic extruded tubes, drip chambers, dialyzer connectors, and injection ports.
The candidate must understand injection-molding design, including wall thicknesses, draft angles, and gating points.
The candidate must be knowledgeable about medical-grade materials and biocompatibility, including polymers suitable for long-term blood contact.
The candidate must understand sterilization compatibility, including gamma radiation, ethylene oxide gas, and steam autoclaving.
The candidate must be able to build prototypes and conduct benchtop experiments to test fluid pressure, flow rates, and mechanical stress tolerances.
The candidate must be able to prepare laboratory test reports, verification protocols, and design-change impact assessments.
The candidate must be able to produce design-output documentation and update the Design History File (DHF) to meet regulatory safety criteria.

Responsibilities

Support intermittent device changes driven by end-of-life changes in electrical components, updates to regulatory material requirements, and drawing updates.
Develop 3D CAD models for mechanical components, casting parts, and structural frames for the dialysis machine platform.
Create high-precision 2D manufacturing drawings with detailed geometric dimensioning and tolerancing (GD&T) for assembly-line production.
Integrate internal hardware, including blood pumps, arterial and venous clamps, and ultrafiltration modules, into the machine's physical layout.
Re-engineer and optimize plastic fluid-path channels to reduce blood shear stress, turbulence, and hemolysis risk.
Design plastic extruded tubes, drip chambers, dialyzer connectors, and injection ports for blood tubing sets.
Design components for high-volume plastic injection molding and select wall thicknesses, draft angles, and gating points.
Evaluate and select medical-grade polymers, such as PVC, polycarbonate, and polyurethane, for direct and long-term blood contact.
Engineer plastic products to withstand gamma radiation, ethylene oxide gas, or steam autoclaving without degradation.
Modify materials and designs on existing platforms to improve product shelf life, lower production costs, and improve environmental sustainability.
Build physical prototypes and conduct benchtop experiments to test fluid pressure, flow rates, and mechanical stress tolerances.
Write laboratory test reports, verification protocols, and design-change impact assessments.
Generate design-output documentation and update the Design History File (DHF) to meet global regulatory safety criteria.

Job Requirements Background of the requirement –As part of product sustenance, Nikkiso has intermittent requirements of doing changes to devices which may require changes in design due to<ol><li>Change in electrical components due to EOL</li><li>Change in material due to updates regulatory requirements</li><li>Updating of drawings</li></ol> To support these activities, person with following skills is required<ol><li>Person should be a Native Japanese engineer with age less than 40 yrs</li><li>Should be good in English language communication to be able to actively communicate with offshore team</li><li>Should have Project management experience</li></ol>要件の背景 –製品の維持管理の一環として、日機装では、以下の理由により設計変更を必要とする可能性のある機器の変更を断続的に行う必要があります。<ol><li>EOLに伴う電気部品の変更</li><li>規制要件の更新に伴う材料の変更</li><li>図面の更新</li></ol>これらの活動を支援するため、以下のスキルを持つ人材を募集しています<ol><li>40歳未満の日本語を母国語とするエンジニアであること</li><li>オフショアチームと積極的にコミュニケーションをとれるよう、英語でのコミュニケーション能力に長けていること</li><li>プロジェクト管理の経験があること</li></ol> Work Experience Technical skillset requirements -1. 3D-CAD Modeling & Mechanical Architecture<ul><li>Structural Engineering: Developing 3D CAD models of mechanical components, casting parts, and structural frames for the Nikkiso dialysis machine platform.</li><li>Manufacturing Drawings: Creating high-precision 2D manufacturing prints with detailed GD&T (Geometric Dimensioning and Tolerancing) to ensure flawless assembly line production.</li><li>Component Integration: Fitting internal hardware—such as blood pumps, arterial/venous clamps, and ultrafiltration modules—into the physical layout of the machine. </li></ul>2. Plastic Medical Device Design (Disposable Components)<ul><li>Fluid Dynamics Optimization: Re-engineering and optimizing the internal channels of plastic fluid paths to reduce blood shear stress, turbulence, and the risk of hemolysis.</li><li>Blood Tubing Set (Bloodlines) Innovation: Designing next-generation plastic extruded tubes, drip chambers, dialyzer connectors, and injection ports.</li><li>Injection Molding Design: Structuring components specifically for high-volume plastic injection molding, selecting optimal wall thicknesses, draft angles, and gating points.</li></ul>3. Material Science & Biocompatibility (Sustenance Activities)<ul><li>Medical-Grade Materials: Evaluating and selecting advanced polymers (like PVC, polycarbonate, or polyurethane) that are safe for direct, long-term blood contact.</li><li>Sterilization Compatibility: Engineering the plastic products to withstand rigorous medical sterilization methods (such as Gamma radiation, ETO gas, or steam autoclaving) without degrading.</li><li>Sustenance Engineering: Conducting material and design modifications on existing platforms to improve product shelf-life, lower production costs, and enhance eco-sustainability.</li></ul>4. Experimental Verification & Design History File (DHF)<ul><li>Prototyping & Lab Experiments: Building physical prototypes and running benchtop experiments to test fluid pressure, flow rates, and mechanical stress tolerances.</li><li>Technical Writing: Writing comprehensive laboratory test reports, verification protocols, and design change impact assessments.</li><li>ISO 13485 & MDR Compliance: Generating strict Design Output documentation and updating the Design History File (DHF) to meet global regulatory safety criteria.</li></ul>求められる技術スキル -1. 3D-CADモデリングおよび機械設計 2. プラスチック製医療機器の設計（使い捨て部品） 3. 材料科学および生体適合性（維持管理業務） 4. 実験による検証および設計履歴ファイル（DHF） <ul><li>構造設計：日機装の透析装置プラットフォーム向けに、機械部品、筐体部品、および構造フレームの3D CADモデルを開発する。</li><li>製造図面：組立ラインでの生産を確実に円滑に行うため、詳細なGD&T（幾何寸法・公差）を盛り込んだ高精度な2D製造図面を作成する。</li><li>コンポーネントの統合：血液ポンプ、動脈／静脈クランプ、限外ろ過モジュールなどの内部ハードウェアを、装置の物理的なレイアウトに組み込む。</li><li>流体力学の最適化：プラスチック製流路の内部チャネルを再設計・最適化し、血液のせん断応力、乱流、および溶血のリスクを低減する。</li><li>血液チューブセット（ブラッドライン）の革新：次世代のプラスチック押出成形チューブ、ドリップチャンバー、ダイアライザーコネクター、および注入ポートの設計。</li><li>射出成形設計：大量生産向けのプラスチック射出成形に特化した部品の構造設計、最適な肉厚、抜き勾配、ゲート位置の選定。</li><li>医療用グレードの材料：血液と直接かつ長期的に接触しても安全な、先進的なポリマー（PVC、ポリカーボネート、ポリウレタンなど）の評価および選定。</li><li>滅菌適合性：プラスチック製品が、劣化することなく、厳格な医療用滅菌方法（ガンマ線照射、ETOガス、蒸気オートクレーブなど）に耐えられるよう設計する。</li><li>サステナビリティ・エンジニアリング：製品の保存期間の延長、製造コストの削減、および環境持続可能性の向上を図るため、既存のプラットフォームに対して材料および設計の改良を行う。</li><li>プロトタイピングおよび実験室実験：物理的なプロトタイプを製作し、ベンチトップ実験を実施して、流体圧力、流量、および機械的応力耐性を試験する。</li><li>テクニカルライティング：包括的な実験室試験報告書、検証プロトコル、および設計変更の影響評価書の作成。</li><li>ISO 13485およびMDRへの準拠：世界的な規制上の安全基準を満たすため、厳格な設計成果物文書を作成し、設計履歴ファイル（DHF）を更新する。</li></ul>

About the Company

Quest Global

Engineering services, digital transformation, asset management

QuEST Global provides engineering and lifecycle services across aerospace, automotive, energy, healthcare, and transportation, focusing on digital transformation and asset management. It uses edge computing, cloud, AI/ML, and industrial IoT to deliver tailored engineering solutions through long-term partnerships, service contracts, project-based engagements, and strategic collaborations. It differentiates itself with a broad industry footprint, global delivery model, and emphasis on partnerships, talent development, and workplace culture. Its goal is to help clients improve operational efficiency and drive business growth by transforming engineering processes and assets with digital tools and data-driven management.

Company size: 10,001+
Company stage: Growth Equity (Venture Capital)
Total funding: $581M
Headquarters: Greenville, SC
Founded: 1997

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