FDA Class II Medical Device Commercial Launch

+95%

WELD YIELD RATE

100%

PDM INTEGRITY

FDA CLASS II

REGULATORY COMPLIANCE

DOCUMENT GAP ERROR

FIG_02: DISPOSABLE ASSEMBLY LASER WELD VALIDATION SETUP

Administered SolidWorks PDM architecture and executed critical validation tests on laser-welding setups for disposable medical accessory launch lines.

VERIFIED DELIVERABLES // DOWNLOADS

BOUGIE_PCB_ASSEMBLY_DRAWINGS.PDF [VIEW]

Engineering Process

Reconfigured SolidWorks PDM networks to streamline design files among R&D, tooling, and quality teams.

Enforced rigid check-in protocols and automatic workflow transitions, preventing conflicting drawing releases during NPI scaling.

Designed custom test jigs to support micro-welding alignment.

Engineered mechanical constraint limits to guarantee consistent laser beam focus on thin-walled stainless steel structures.

Conducted full IQ/OQ/PQ protocols on sub-contractor laser welding platforms.

Oversaw physical pull-tests and leakage assessments, reducing batch defect rates to less than 0.5% for international shipment.

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.