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FDA Class II Medical Device Commercial Launch

-50%
DESTRUCTIVE TESTING
>50%
PROCESS TIME REDUCED
FDA CLASS II
REGULATORY COMPLIANCE
100%
PDM INTEGRITY
FIG_02: DISPOSABLE ASSEMBLY LASER WELD VALIDATION SETUP
Stage 1: Alignment Jig
Stage 2: Weld Station
Constraint Solved: Redesigned concentric jig preventing thermal warping and ensuring error-proof alignment.
Constraint Solved: Optimized laser welding parameters with gas shielding, reducing destructive sampling by 50%.
01 // SITUATION

Led NPI process redesign and tooling qualification for high-delicacy, low-yield laser welding processes under strict FDA regulatory constraints.

02 // TASK

An internal delicate laser welding process needed a redesign. Due to its delicacy, skill-dependent high cost/risk, and very low yield, the challenge was complex—especially since regulatory restrictions prohibited major process modifications.

03 // ACTION

Utilized 5-Why root cause analysis and Kaizen principles to redesign all process jigs for error-proofing (Poka-Yoke). Rewrote SOPs to reduce operator dependency, automated steps, and optimized IQ/OQ/PQ sample sizes.

04 // RESULT

Reduced destructive testing by 50%, cut process cycle time by >50%, improved laser welding yields by 30%, and successfully qualified technicians who had previously failed qualification.

Situation: Led NPI process redesign and tooling qualification for high-delicacy, low-yield laser welding processes under strict FDA regulatory constraints.

VERIFIED DELIVERABLES // DOWNLOADS

BOUGIE_PCB_ASSEMBLY_DRAWINGS.PDF [DOWNLOAD]