Yilin Wu

Product manager @ Advantech

About

[ Strategic Medical Product Leader | Global Account Management | x86 & ARM Systems ] I am a results-driven Product Manager with a unique professional trajectory: bridging the gap between frontline clinical practice and high-tech medical computing integration. With over 9 years of experience, I specialize in translating complex clinical workflows into high-performance technical solutions for global healthcare markets. 🌍 Global Impact & Strategic Account Management Currently, I manage Tier-1 Global Medical Key Accounts with annual revenues exceeding $40M USD. My expertise lies in overseeing the full lifecycle (NPI) of specialized x86 and ARM-based platforms, ensuring that global industry leaders receive medical-grade products that are not only technically superior but also commercially successful and compliant. 🛠 Core Expertise • Full Lifecycle Management (NPI): Expert in leading complex medical projects from RFQ to Mass Production (MP), with a focus on strict BOM cost control and strategic time-to-market. • Technical Leadership: Proven ability to coordinate cross-functional engineering teams (EE/ME/FW/SW) to resolve technical bottlenecks in Medical AIO and Surgical Imaging systems. • Regulatory & Quality Excellence: Proficient in navigating complex compliance landscapes, including FDA (510K), EU MDR, and ISO 14971, ensuring 100% product-market success. • The Clinical Edge: As a former Respiratory Therapist, I bring an unparalleled "user-first" perspective to product design, ensuring Usability (IEC 62366) and patient safety are at the heart of every innovation. 💻 Technical Toolkit • Platforms: x86, ARM Architecture (RK3399). • Regulatory/Standards: ISO 13485, IEC 60601-1, IEC 62366. • Systems: SAP, PLM, MS Project. • Design & Analysis: AutoCAD, Solidworks, ANSYS Fluent (CFD).

Country

City

Taiwan

Industry

Medical Device

Skill

產品管理, key acount, NPI Management, IEC 62368, Cross-functional Communication, 電腦硬體, 產品生命週期管理, SAP PM Module, Product manage, Medical Device Product Development, OEM Management, Risk Assessment, Risk Management, ISO 13485, Usability Testing, Clinical Trials, Clinical Research, Project Management, ISO 9001, FDA

Experience

Product manager

Advantech

2022-9 - Present · 4 yrs 1 mo

- Strategic Portfolio Management: Direct oversight of a $40M+ annual revenue global medical portfolio for industry-leading Tier-1 key accounts (Global Market Leaders). Responsibilities include optimizing account revenue and aligning NPI with market demands. - NPI Leadership & Technical Translation: Directed the full-lifecycle NPI process for specialized medical-grade x86/ARM systems, surgical imaging, and Medical All-in-One (AIO) platforms, ensuring on-time mass production (MP). Effectively translated clinical needs into detailed technical PRDs. - Global Compliance Excellence: Ensured all products met rigorous global healthcare standards, navigating complex international requirements including ISO 13485 and product safety for Tier-1 clients. - Cross-Border Orchestration: Coordinated complex global projects between R&D, Supply Chain, and international Tier-1 clients to resolve bottlenecks and optimize technical specifications for diverse market standards.

Product Manager

Heroic-Faith Medical Science

2019-3 - 2022-9 · 3 yrs 7 mos

- "0 to 1" Medical NPI: Spearheaded the full development lifecycle of a pioneering AI-powered respiratory monitoring system from original concept through clinical validation to successful market launch. - Regulatory Triumph: Successfully secured US FDA (510k) and TFDA certifications by authoring rigorous technical documentation, managing clinical trial data analysis, and spearheading a complete medical-grade risk management strategy. - Market Strategy Development: Led technical marketing initiatives, gathered and prioritized clinical user needs, and orchestrated product feature roadmaps to ensure market-product fit.

Engineer

National Taiwan University

2016-9 - 2019-1 · 2 yrs 5 mos

- Advanced Fluid Modeling & Optimization: Utilized high-precision CFD (ANSYS Fluent) for pollutant distribution analysis, providing crucial data modeling for optimizing medical and high-reliability system designs. - Technical Bottleneck Resolution: Conducted advanced data modeling to resolve complex airflow and pollutant distribution challenges, enhancing the reliability and user safety of complex hardware platforms.

Respiratory Therapy Supervisor

Kaohsiung Chang Gung Memorial Hospital

2013-7 - 2016-7 · 3 yrs 1 mo

- Full-Spectrum Clinical Workflow Mastery: Extensive rotations across Internal Medicine, Surgery, Obstetrics, Pediatrics, ER, and ICU, gaining deep insights into diverse clinical workflows and specialized patient care environments. - Clinical Pain Point Identification (UX/Usability): Leveraged 3+ years of frontline experience to identify critical gaps in medical device usability and patient safety. My direct clinical insights now serve as the foundation for translating user needs into high-reliability product specifications. - High-Stakes Device Operation: Managed complex respiratory and life-support systems in high-pressure environments, ensuring 100% operational efficacy and patient safety. - Cross-Functional Clinical Feedback: Provided expert-level feedback on medical equipment performance to hospital procurement and technical teams, bridging the gap between clinical efficacy and technical requirements.