職種概要
Own design-phase quality for an AI-based ultrasound diagnostic SaMD intended for both PMDA and FDA markets. This is a device program inside a pharma organization — the role carries an explicit build-the-capability mandate, not just execution against an existing device QMS.
必要条件
Design Quality Assurance Engineer — SaMD (Digital Diagnostics)
Location: Tokyo (hybrid) · Level: Senior / Lead
Nationality: Japanese.
Purpose
Own design-phase quality for an AI-based ultrasound diagnostic SaMD intended for both PMDA and FDA markets. This is a device program inside a pharma organization — the role carries an explicit build-the-capability mandate, not just execution against an existing device QMS.
Responsibilities
• Support design controls for a software-only device: DHF, design inputs/outputs, traceability, V&V, design transfer, and change assessment under 21 CFR 820 / QMSR and MHLW Ordinance 169.
• Supporting quality oversight of the IEC 62304 software lifecycle (Class B/C), including SOUP, architecture, and unit/integration/system verification evidence.
• Risk management per ISO 14971 / JIS T 14971 with attention to AI-specific failure modes — false negative on joint pathology, degraded image quality, out-of-distribution inputs, automation bias.
• Cybersecurity per IEC 81001-5-1 and FDA premarket cybersecurity guidance; MHLW cybersecurity notification alignment.
• Supplier/development-partner quality oversight — outsourced software development, annotation vendors, cloud infrastructure. Design control does not transfer with the work.
• Dual-pathway change management: FDA PCCP scope vs. new 510(k)/De Novo, and Japan partial change approval (一部変更承認) vs. minor change notification (軽微変更届).
• Submission support: PMDA Shonin/Ninsho consultation and clinical evaluation package, plus FDA submission evidence; audit and inspection readiness.
Required
• 7+ years medical device quality, 4+ in design assurance, with substantial software/SaMD exposure
• IEC 62304, ISO 14971, IEC 62366-1, ISO 13485:2016. Familiarity with IMDRF SaMD risk categorization and ISO 82304-1.
• Experience with at least one AI/ML-enabled device or a clinical decision support product.
• Business-level Japanese and English — audit-capable in Japanese, documentation authoring in both.
• Comfortable operating where the sponsor’s QMS is pharma/GxP-shaped and device design controls must be layered in.
Nice to have
• Medical imaging background — ultrasound, DICOM/PACS, radiology AI. Hemophilia or musculoskeletal imaging is a bonus, not a gate.
• Familiarity with Japan’s SaMD acceleration schemes (DASH for SaMD / two-step approval) and PMDA AI consultation practice.
• Clinical performance study support: reader studies, ground truth definition, statistical acceptance criteria.
• Dual-jurisdiction fluency: FDA design controls and Japan PMD Act (薬機法) + Ordinance 169 — able to articulate where they diverge, especially on software change control.
• ISO 13485 lead auditor certification.
• Experience with AI/ML-specific quality: training/validation/test data provenance and separation, dataset representativeness, annotation protocol and inter-reader agreement, model performance acceptance criteria, drift monitoring, and locked-vs-adaptive model strategy.
• Experience with Interoperability and data quality evidence: DICOM conformance, PACS integration, de-identification, and cross-site image variability.
• 設計品質保証エンジニア-SaMD (デジタル診断)
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• 所在地:東京 (ハイブリッド) ·レベル:Senior/Lead
• 国籍：日本籍
• 目的
PMDAとFDAの両方の市場を対象としたAIベースの超音波診断用SaMDの独自の設計フェーズ品質。これは製薬組織内のデバイスプログラムです。このロールには、既存のデバイスQMS(Quality Management System)に対して実行するだけでなく、明示的な能力構築の義務があります。
[責任]
•ソフトウェアのみのデバイスの設計管理をサポートします。DHF、設計の入力/出力、トレーサビリティ、V&V、設計の転送、および21 CFR 820/QMSRおよびMHLW Ordinance 169に基づく変更評価。
•IEC 62304ソフトウェアライフサイクル (クラスB/C) の品質監視をサポートします。これには、SOUP、アーキテクチャ、ユニット/統合/システム検証の証拠が含まれます。
•AI固有の障害モードに注意して、ISO 14971/JIS T 14971に従ってリスク管理を行います。関節の病理、画質の低下、配信外の入力、自動化バイアスの偽陰性。
•IEC 81001-5-1およびFDA市販前のサイバーセキュリティガイダンスに基づくサイバーセキュリティ;厚生労働省のサイバーセキュリティ通知の調整。
•サプライヤー/開発パートナーの品質監視:アウトソーシングされたソフトウェア開発、注釈ベンダー、クラウドインフラストラクチャ。設計管理は作業には移行されません。
•デュアルパス変更管理:FDA PCCPスコープと新しい510 (k) /De Novo、および日本の部分変更承認 (一部変更承認) とマイナー変更通知 (軽微変更届) 。
•提出サポート:PMDA Shonin/Ninshoコンサルテーションおよび臨床評価パッケージに加えて、FDA提出証拠;監査および検査の準備。
[必須]
•医療機器の品質管理に7年以上、設計保証に4年以上、ソフトウェア/SaMDの経験が豊富
•IEC 62304、ISO 14971、IEC 62366-1、ISO 13485:2016。IMDRF SaMDリスク分類およびISO 82304-1に精通。
•少なくとも1つのAI/ML対応デバイスまたは臨床意思決定支援製品の経験。
•ビジネスレベルの日本語および英語 (日本語で監査可能、両方でドキュメント作成) 。
•治験依頼者のQMSが製薬企業/GxP型であり、デバイス設計コントロールが階層化されている必要がある場合に、快適な運用。
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あると便利
•医用画像の背景:超音波、DICOM/PACS、放射線AI。血友病や筋骨格の画像はおまけであり、ゲートではない。
•日本のSaMD加速スキーム (DASH for SaMD/二段階承認) とPMDAのAIコンサルテーション実務に精通。
•臨床パフォーマンス研究のサポート:リーダー研究、グラウンドトゥルースの定義、統計的受け入れ基準。
•二重管轄の流暢さ:FDAの設計統制と日本PMD法 (薬機法) +条例169。特にソフトウェア変更管理に関して、どこが異なるかを明確にすることができる。
•ISO 13485リード監査人認定。
•AI/ML固有の品質に関する経験:トレーニング/検証/テストデータの出所と分離、データセットの代表性、注釈プロトコルとリーダー間の合意、モデルパフォーマンスの受け入れ基準、ドリフトモニタリング、ロック対適応モデル戦略。
•相互運用性とデータ品質の証拠に関する経験:DICOM準拠、PACS統合、非識別、およびクロスサイト画像の可変性、設計品質
職務内容
• Support design controls for a software-only device: DHF, design inputs/outputs, traceability, V&V, design transfer, and change assessment under 21 CFR 820 / QMSR and MHLW Ordinance 169.
• Supporting quality oversight of the IEC 62304 software lifecycle (Class B/C), including SOUP, architecture, and unit/integration/system verification evidence.
• Risk management per ISO 14971 / JIS T 14971 with attention to AI-specific failure modes — false negative on joint pathology, degraded image quality, out-of-distribution inputs, automation bias.
• Cybersecurity per IEC 81001-5-1 and FDA premarket cybersecurity guidance; MHLW cybersecurity notification alignment.
• Supplier/development-partner quality oversight — outsourced software development, annotation vendors, cloud infrastructure. Design control does not transfer with the work.
• Dual-pathway change management: FDA PCCP scope vs. new 510(k)/De Novo, and Japan partial change approval (一部変更承認) vs. minor change notification (軽微変更届).
• Submission support: PMDA Shonin/Ninsho consultation and clinical evaluation package, plus FDA submission evidence; audit and inspection readiness.
私たちが提供するもの
Exciting Projects: We focus on shaping, defining, and advising product strategy for digital transformation initiatives of our clients in Japan. Our customer list is full of fantastic global brands and leaders across industries who love what we build for them.
Collaborative Environment: You Can expand your skills by collaborating with a diverse team of highly talented people in an open, laidback environment — or even abroad in one of our global centers or client facilities!
Work-Life Balance: GlobalLogic prioritizes work-life balance, which is why we offer flexible work schedules, opportunities to work from home, and paid time off and holidays.
Professional Development: Our dedicated Learning & Development team regularly organizes Communication skills training, Stress Management program, professional certifications, and technical and soft skill training.
Excellent Benefits: We provide our employees with competitive salaries, Workers’ Accident Compensation Insurance, Unemployment Insurance, Health Insurance, and Nursing Care Insurance, Employees’ Pension Insurance, Annual Health Check-up, Housing Allowance, Commuting Allowance, Family Allowance, Condolence Allowances ( covers Marriage, Wellness, Childbirth, and Death Allowances ), Natural Disaster Allowance, Annual performance bonuses, and Referral bonuses.
Fun Perks: We want you to love where you work, which is why we host sports events, cultural activities, offer food on subsidies rates, Corporate parties. Our vibrant offices also include dedicated GL Zones, rooftop decks and GL Club where you can drink coffee or tea with your colleagues over a game of table and offer discounts for popular stores and restaurants!
GlobalLogicについて
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.
