Yoav Schatzman
Medical Device NPI Project Manager Dublin, Ireland
Medical Device NPI Project Manager, experienced in end-to-end project delivery, R&D scale-up, validation, and production transfer under ISO 13485 & FDA Class II regulations. Proven track record driving cross-functional teams and implementing advanced metodologis to achive project objectives in scope.
Horizontal Career Timeline
From current medical surgical robotics integration back to lithography tooling scale-up at Intel. Scroll horizontally to inspect NPI milestones and yield optimization metrics.
"Medical device NPI engineering is the art of process composition, rigorous project management, Kaizen continuous improvement, and empowering cross-functional teams."
— Yoav SchatzmanNITINOTES SURGICAL
Medical Device NPI Project Manager
- 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.
- 1st Commercial Launch ramp up
- Implement new Part numbers in all product BOMs
- Improve motors QC test by 30%
- Welding process validation destructive test reduction by 60%
- Laser welding process yield improvement by 30%
FORSIGHT ROBOTICS
Medical Device NPI Project Manager
- 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.
- Established and managed DMR (Windchill) to freeze of 3000 parts
- Project owner of system Harnesses and PCBA's of 600 parts
REE AUTOMOTIVE
Product Development & NPI Project Engineer
- 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.
- Total Cost of Ownership reduction by 20%
- Led 2 Monetization projects using vehicle sensors platform
SOFTWHEEL (UNDER REE)
Technical Product Owner & NPI Project Engineer
- 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.
- Launched 4 manufacturing lines.
- Oversaw 2 product cycles, from requirements through R&D to MFG and distribution.
- Ramped up production from R&D to distribution of 10K+ Annually.
- 90% serviceability satisfaction through fast response and problem solving.
INTEL CORPORATION (FAB 28)
Process Engineer & Project Lead
- 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.
- Team of 5 Integrators, $1M+ Annual Savings
INTOVISION DESIGN
R&D & NPI Engineer
- 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.
- Full NPI Lifecycles (1yr 11mo)
02 // ENGINEERING CASE STUDIES
Horizontal Experience Library
Deep dives into multi-systems engineering challenges, product ownership cycles, and transitioning R&D designs to commercial cleanroom manufacturing.
1st product implementation - Surgical Robotic Arm Multisystem
Situation: Oversaw ophthalmic surgical arm multisystem NPI: Modules objectives, PLM (Windchill) infrastructure, quality, schedule, and ISO 13485 DMR compliance.
FDA Class II Medical Device Commercial Launch
Situation: Led NPI process redesign and tooling qualification for high-delicacy, low-yield laser welding processes under strict FDA regulatory constraints.
Automotive Wheel Suspension & EV Platforms
Situation: Spearheaded end-to-end NPI launch, scope, and product requirements (PRDs/MRDs) for shock-absorbing wheel suspension products across global factories.
Replacement of Contractor Work to Inhouse Full Process
Situation: Sourced, qualified, and fully transitioned a critical rims manufacturing process from an external contractor to an in-house 3D rolling station under ISO 13485.
03 // TECHNICAL PROFILE
Reliability & Scale
I help scale R&D prototypes into automated mass production, combining project management with practical process design and data infrastructure.
I love the creativity of it, the collaborative challenges of hardware engineering and the feeling of creation—you can see the outcomes in the case studies below.
FOCUS_AREAS: [SYSTEMS_INTEGRATION, DFM_DFA, PROCESS_QUALIFICATION, COMPLIANCE]
PM & Quality Methodologies
Design & PLM
Manufacturing Processes
Standards & Compliance
Education & Certifications
Rigorous engineering foundation combined with product management methodology. Click on institutions to verify credentials.
Academic Degrees
Tel Aviv University
Major subject: Electromechanical mechanisms Thesis on Computer Science theories applied to Mechanical Mechanisms under Prof. Ofer Shai.
Ben-Gurion University
Major subject: Thermodynamics and mechanical design Graduation project at Negev Nuclear Research Center: Capillary High-Capacity Heat Pipe design and testing.
Certifications & Education
Specialized curriculum in **Product Management** bridging design engineering, customer acquisition, and market strategies.
Introduction to Product Marketing Management (Certifications in product positioning, messaging, and go-to-market strategy).
Specialized configuration and infrastructure administration for multi-departmental SolidWorks PDM environments.
Formal training in requirements definition, interface verification, and validation metrics for complex multi-disciplinary hardware assemblies.
Formal mentoring training focused on leading cross-functional teams, developer onboarding, and collaborative project execution.
Characteristics & Athletic Drive
Systemic Execution Core
DATA-DRIVEN DECISIONS
Utilizing rigorous Statistical Process Controls (SPC) and performance modeling to make definitive architectural engineering choices.
LEAN NPI RUNTIME
Directing product development using structured waste elimination, DFM pipelines, and modular manufacturing configurations.
CROSS-FUNCTIONAL LINK
Connecting advanced physics research teams with global manufacturing plants and regulatory bodies (FDA, CE, TUV).
Elite Physical Focus
Applying the same mental toughness required for complex systems engineering to open-sea endurance swimming, marathons, and triathlons.
Victorian Restoration
Restoring Victorian-era structural properties with thermodynamic building energy rating (BER) upgrades, applying structural analysis to historic envelopes.
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Let's build something exceptional.
Open to new opportunities, technical leadership roles, and engineering scale-up initiatives. Feel free to reach out directly.