Shwe Pyie
Sr Manufacturing Engineer at Johnson & Johnson Vision
- Role
- Sr Manufacturing Engineer at Johnson & Johnson | Vision
- Location
- Newark, CA, US
- LinkedIn followers
- 500 followers
Experience
Sr Manufacturing Engineer
Apr 2023 — Present · Milpitas, CA, US
Own day-to-day manufacturing support for an assembly and test product line, driving safety, quality, delivery, and cost performance for eye surgical (cataract and laser) equipment.• Lead continuous improvement initiatives to improve process capability, reliability, and cost; partner with technicians and operators to troubleshoot issues and implement fixes.• Reduced the Out of Box failures from 3% to 1% and Pre-delivery Inspection failures from 30% to 17% by addressing the quality issue of cataract product related to screws and provided cost savings of $200k per year.• Plan and execute process validations/qualifications (IQ/PQ/PV) and maintain a compliant validation lifecycle within a regulated environment.• Lead end-of-life (EOL) activities to update the chip of treatment cards including technical risk assessment, transition planning, and controlled implementation to secure revenue of $28M per year. • Provide technical disposition for nonconforming material; perform root-cause investigations and collaborate with suppliers to drive corrective actions. • Successfully completed project of design changes (hardware and software) for regulatory compliance to continue manufacturing of high cost laser product ($300k) by implementing the process changes and updating BOMs. Worked cross-functionally Purchasing, Planning, Regulatory, Field Service, Quality, and R&D.• Implement change orders impacting BOMs, manufacturing instructions, and controlled documentation to ensure accurate build and traceability.• Yellow Belt Certified – Eliminated non-conformace issue with PCBAs from 75% to 0% by identifying the root cause and requiring supplier to test the battery voltage.
Education
UC Irvine
Engineering, Bioengineering
2008 — 2012
Skills
- Matlab
- Medical Devices
- Python
- Cgmp
- Western Blotting
- Microsoft Office
- Sop
- Fda
- Gdp
- Immunoprecipitation
- Immunofluorescence
- Gmp
- Manufacturing
- Solidworks
- Iso 13485
- Assay Development
- Biomedical Engineering
- Technical Writing
- Labview
- Biotechnology
- Validation
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.