Medical Device NPI Project Manager
Dublin, Ireland
Medical Device NPI Project Manager
Location: Dublin, Ireland | Email: joavsc@gmail.com | LinkedIn: linkedin.com/in/yoav-schatz | Portfolio: yoavschatzman.com
Medical Device NPI Project Manager | NITINOTES SURGICAL (Dublin, Ireland)
MAY 2025 - PRESENT
Managing project of complex hybrid surgical system modules. From R&D to cleanroom manufacturing under ISO 13485, to meet objectives in scopes Oversee objectives and success criteria for product motor units ramp-up and disposable accessory bundles, stabilizing production yields and achieving its defined requirements. Implementor, Admin and Configurator of SolidWorks PDM, establishing cross-teams project workflows. Design and qualify custom assembly/validation jigs, testing machinery, and plastic disposables with global suppliers via IQ/OQ/PQ protocols.
Medical Device NPI Project Manager | FORSIGHT ROBOTICS (Israel / Dublin)
NOV 2023 - MAR 2025
Medical Device NPI Project Manager for complex ophthalmic surgical robotic arms, executing 1 product full DMR freeze (3,000+ parts). Led cross-functional teams of integrators and engineers, utilizing 8D problem-solving to resolve complex multi-disciplinary hardware and quality deviations. Managed project scope, schedule, cost, and risk mitigation between R&D, Operations, and QA through CDRs, IQ/OQ/PQ, and FDA Class II compliance. Architected Windchill PLM infrastructure from scratch to ensure strict ISO 13485 traceability for First-in-Human clinical operations.
Product Development & NPI Project Engineer | REE AUTOMOTIVE (Tel Aviv / Global)
AUG 2015 - JUL 2023
Coordinated design definitions and end-to-end project delivery across multi-disciplinary global R&D teams for vehicle scale-up. Technical Project Manager leading product, production, and serviceability infrastructure for commercial Electric Vehicle platforms. Applied Kaizen continuous improvement and data-driven risk management to achieve a 20% TCO reduction while meeting strategic partner milestones.
Technical Product Owner & NPI Project Engineer | SOFTWHEEL (UNDER REE) (Tel Aviv, Israel)
AUG 2015 - MAR 2020
Recruited and led a cross-functional team of 6 engineers, integrators, and QC professionals to consistently achieve company and customer KPIs. Technical Product Owner managing 2 end-to-end product development cycles from market requirements (MRD/PRD) to mass manufacturing. Led 4 global manufacturing line ramp-ups across N. America and Europe, applying 5-Why root-cause analysis to optimize assembly quality. Secured FDA Class II and CE regulatory compliance, executing DMR Freeze for product mass distribution across 30 countries.
Process Engineer & Project Lead | INTEL CORPORATION (FAB 28) (Kiryat Gat, Israel)
JUN 2012 - FEB 2015
Process and Tool Engineer in the Lithography department at Fab 28, managing advanced semiconductor fabrication tooling. Served as technical leader for a team of 5 process integrators to optimize tool uptime and yield via 8D root-cause investigations. Directed cross-functional cost reduction (DFC) projects, achieving over $1M in verified annual savings. Established statistical process control (SPC) models to monitor manufacturing deviations and reduce defect densities.
R&D & NPI Engineer | INTOVISION DESIGN (Tel Aviv, Israel)
NOV 2009 - SEP 2011
R&D and NPI Engineer executing product development, SolidWorks 3D CAD modeling, prototyping, and stress analysis. Spearheaded new product introduction tasks including Design for Manufacturing (DFM), Bill of Materials (BOM) structure, and Statement of Work (SOW). Managed product life-cycle workflows including Design History Records (DHR), ECOs, and PLM database administration. Executed installation, operational, and performance qualification (IQ/OQ/PQ) protocols for manufacturing verification.
M.Sc. Mechanical Engineering | Tel Aviv University
Thesis on Computer Science theories applied to Mechanical Mechanisms under Prof. Ofer Shai.
B.Sc. Mechanical Engineering | Ben Gurion University
Graduation project at Negev Nuclear Research Center: Capillary High-Capacity Heat Pipe design and testing.
PM & Quality Methodologies: SMART Goals, 8D Problem Solving, 5-Why Analysis, Kaizen & Lean, Risk Management (ISO 14971), PMP Principles, WBS & Scope Management, IQ/OQ/PQ Protocols
Design & PLM: SolidWorks, ANSYS, ROS2, CAD Modeling, DFMA, PDM, Windchill, ERP
Manufacturing Processes: Extrusion, Precision Laser Welding, Forging, Swiss-type Machining, Injection Molding, Coating & Adhesives, PCBA, Harnesses, PLC
Standards & Compliance: FDA Class II, ISO 13485, ISO 14971, IQC/OQC Verification, DMR / DHR Management