Manufacturing Mechanical

Sr Manufacturing Technician with over ** years of experience in helping a medical start-up company reach CE Mark and continuing to advance towards FDA approval. I am a motivated team player who’s always willing to learn, able to take instructions from all levels, and build up good working relationships with all colleagues.

Experience

Sr Manufacturing Technician, OPTISCAN BIOMEDICAL CORPORATION – Hayward, CA Feb 2003 to Present

Manage multiple projects where deadlines and priorities are always changing

Construct, troubleshoot, adjust, test, setup and maintain equipment for various optical, mechanical, electrical, fluidic parts, PCBA boards, devices or systems

Create and revise Work Instructions, Test Procedures, Lot History Records, and Device History Records to support manufacturing operations

Work from schematics, engineering drawings, and written or verbal instructions

Conduct V&V testing, Production Test Protocols, and report data in prescribed format

Determine the status and disposition of products

Recommend and implement changes to and or modify fixtures and equipment to improve performance

Support Manufacturing and Quality in assembly and/or inspection of components

Provide guidance and training to other technicians

Collaborate with various groups to resolve quality issues related to products

Provide support to avoid or minimize downtime and ensure proper operation and maintenance of equipment

Support company goals and objectives, policies and procedures, Quality System Regulation, and FDA/MDD regulations

Work with vendors to find appropriate parts and components

Facilitate the layout of 100k clean room and maintain Continuous Flow Manufacturing

Skills

Familiar with UV bonding techniques and working with a variety of UV adhesives

Excellent mechanical skills, knowledge of mechanical tools and measuring equipment, and able to understand product and tool drawings

Knowledge of ESD requirements and usage

Knowledge of FDA Good Manufacturing Practices, ISO 13485-2003

Machine shop knowledge and skills

Working knowledge of SolidWorks

Qualifications

High attention to detail and processes

Great organizational skills

Strong interpersonal abilities

Excellent verbal and written communication

Education

DeVry University, Fremont CA (2006)

Bachelor of Science in Technical Management

References Available upon request

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