Ophthalmic Surgical Robotic Arms

99.8%

REPEATABILITY YIELD

-30%

DEV CYCLE TIME

CLASS II

FDA COMPLIANCE

ISO 13485

QUALITY STD

FIG_01: INTRAOCULAR ARM SEGMENT KINEMATICS

Directed NPI integration, tooling design, and manufacturing compliance validation for multi-million dollar ophthalmic surgical arm assemblies.

VERIFIED DELIVERABLES // DOWNLOADS

INTERCONNECTION_DIAGRAM.PDF [VIEW] ORYOM_MFG_FLOW_CHART.PDF [VIEW]

Engineering Process

Established rigid BOM hierarchies and sub-assembly structures in SolidWorks PDM.

Managed configurations to isolate critical component tolerances, ensuring precise clearance margins for surgical-grade optical components.

Coordinated revisions through official Engineering Change Orders (ECOs) directly mapped into Windchill PLM.

Built custom laser-welding fixtures and alignment jigs to reduce assembly errors during pilot builds.

Optimized part geometry for Swiss-type machining and precise anodized coatings.

Formulated detailed Assembly flowcharts, standard operating procedures, and Device Master Records (DMR) to transfer fabrication from R&D to factory floor operations.

Executed standard Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for automated calibration benches.

Coordinated First Article Inspections (FAI) and Material Review Board (MRB) dispositions to assure 99.8%+ production repeatability yield metrics.

Work Experience

NPI Project Manager | Nitinotes Surgical (Dublin, Ireland)

2024 - Present

Led manufacturing ramp-up and transfer of hybrid complex medical devices.
Oversaw DMR (Device Master Record), BOM structures, assembly workflows, and verification tests.
Utilized SolidWorks and Windchill PLM to drive DFA/DFM compliance.

Project & Engineering Manager | SoftWheel / REE

2015 - 2024

Built 6 medical products from prototype to global sales.
Managed 4 manufacturing lines ramp up: Alubin (Israel), RH (Israel), Delphi (Czech Republic), Linamar (Canada).
Established 2 service centers in Germany and Chicago.
Recruited and managed a team of 6 R&D/MFG engineers and integrators.

Process & Tool Engineer (Lithography) | Intel Corporation (Fab 28)

2012 - 2015

Led technical management of 5 operators crew.
Implemented SPC build and controls, complex machine ownership.
Directed cost reduction (DFC) projects yielding $1M+ yearly savings.

Student R&D Engineer | Intovision Design

2010 - 2012

Research and development of automatic Stalband insert machines.
Completed design for manufacturability (DFM) of unique lock mechanisms.

Education

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.

Technical Skills

Design & PLM: SolidWorks, SolidWorks PDM, Windchill PLM, CAD modeling, DMR, DHR, ECO, FAI, MRB, BOM.
Manufacturing Processes: Extrusion, Welding, Forging, Punching, Swiss-type Machining, Injection Molding, Adhesives, Coating.
Materials: Carbon Fiber, Plastics, Aluminum, Magnesium, Stainless Steel.
Standards & Compliance: FDA & CE compliance, TUV Certification, IQC, OQC, IQ, OQ, PQ.