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1st product implementation - Surgical Robotic Arm Multisystem

3,000+
PARTS DMR OWNED
1 Alpha
FULL DMR FREEZE
CLASS II
FDA COMPLIANCE
ISO 13485
QUALITY STD
FIG_01: INTRAOCULAR ARM SEGMENT KINEMATICS
Image 1: Finished Robotic Arms Assembly
Image 2: Modeling and DMR Writing
Image 3: System Modules Complex Assembly
Constraint Solved: Dual surgical robotic arms integration and validation for cleanroom operation.
Constraint Solved: Complete 3D CAD modeling and 3,000+ parts DMR freeze for Windchill PLM.
Constraint Solved: High-precision structural chassis integration and encoder routing.
01 // SITUATION

Oversaw ophthalmic surgical arm multisystem NPI: Modules objectives, PLM (Windchill) infrastructure, quality, schedule, and ISO 13485 DMR compliance.

02 // TASK

Achieving a full DMR freeze of 1 alpha system under tight deadlines while managing technical risks, new suppliers, and continuous design revisions.

03 // ACTION

Managed 3,000-part DMR ownership (Assembly Instructions, DHR, Bringup Jigs, Acceptance Criteria). Applied 8D problem-solving with machining, PCBA, and harness vendors, executing IQ/OQ/PQ protocols and establishing SMART performance KPIs.

04 // RESULT

Successfully completed the full DMR freeze for the 1 alpha system, establishing qualified supply chains, robust risk mitigation, and engineering data controls.

Situation: Oversaw ophthalmic surgical arm multisystem NPI: Modules objectives, PLM (Windchill) infrastructure, quality, schedule, and ISO 13485 DMR compliance.