Engineer Medical

Anastasiya Agafonova *********@*****.*** cell 857-***-****

Houston, TX

Summary

Made my way from an entry-level position to an Engineer level with managerial responsibilities in medical devices manufacturing field by constantly learning new techniques, working hard, and wearing many hats at a small company. Taking a product from design concept stage to the production through all the phases as R&D, product design, personnel training, quality control and testing. Following Six-Sigma and Lean manufacturing methods, ensuring ISO 13485 and FDA’s GMP for Medical Devices compliance. As a detail-oriented person conduct planning and designing the product, documenting it, assembling, and testing the device to confirm the assembled product is the highest quality. Software: any version of AutoCAD, MS Office 98-16, Mac and PC environment. Certified Salesforce.com Administrator (ADM 201). Skills: Salesforce Administration, HTML, CSS. Experience

Lake Place Design 06/2015-present

Certified Salesforce.com Administrator

• Worked with senior Salesforce developer implementing companies needs and requests within Salesforce environment

• Designed and developed custom apps, objects, tabs, fields, components, record types, dashboards and reports, validation rules to suit the needs of the application

• Used field level security along with page layout to manage the visibility and accessibility of fields for different profiles, customized sharing rules

• Developed workflow rules, approval processes, tasks, emails and alerts to track customer related activities

• Maintained user roles, profiles, security, permission sets and role hierarchy

• Migrated data using Import Wizard, Apex Data Loader MicroVision, Inc 2009 - 2015

Engineer, R&D (Promotion) 04/2011– 06/2015

• Researched and developed new products and design concepts for multi-step and one-step product assemblies, established guidelines by describing operational and testing methods in the Device Master Records, Manufacturing Procedures, created BOM, AutoCAD drawings, documented Validation Procedures, Standard Operating Procedures

• Reduced one of the product lines reject percentage from 85% to 3% by researching, analyzing, redesigning manufacturing process, retraining assembly department

• Trained and supported 3 departments of 10 employees during new product assembly, administered QC inspections, and ensured on-time delivery. Transferred 40 products from European manufacturer to produce and to market global consumers

• Decreased product assembly time by 30% across 2 production departments, minimized production cost by 15% by revising process and materials, performing troubleshooting to identify issues

• Significantly increased job knowledge repository by tracking and understanding emerging engineering practices, participating in training and professional events, reading professional publications Managerial responsibilities

• Supervised, coached and mentored up to 15 team members to foster a collaborative, productive work environment, provided yearly performance reviews, and recommended performance improvements

• Worked with production planning team to schedule operations, ensured equipment and employees were effectively utilized

• Trained all team members to follow established production, safety, quality, and environmental practices and procedures, provided SOP training

• Managed and tracked equipment and preventative maintenance activities Quality Control Specialist (Promotion) 02/2010 – 04/2011

• Carried out procedures to ensure that all products meet organization standards and end-user requirements

• Reported on findings and made recommendations on changes to meet specifications and quality standards

• Provided overall management functions that determine, defines, and implements QA/QC policies, programs, and procedures, reported progress on problem resolution to management

• Improved product quality, reject quantity decreased by 10-15% Production Inspector 03/2009 – 02/2010

• Inspected products for various defects visually and under microscope, setup, adjusted, and operated equipment such as inspection machines, labelers

• Performed and documented critical start-up procedures for line clearance, component verification, quality checks on product, calculated percent defective on inspection results and reconciles components on batch record

• Counted and verified accuracy of product, labeling material, and components used Education and Certifications

• Certified Salesforce.com Administrator (ADM 201) 2016

• Master of Science in Mathematics at Bashkir State University, Russia 2007

• Bachelor of Arts in Business with Concentration in Management at University of New Hampshire 2013

• ISO 13485 Quality Management Standard for Medical Devices at CALISO Corporation 2014

• Interactive FDA’s GMP for Medical Devices at CALISO Corporation 2014

• AutoCAD at CAD Training Center at the Thompson School of Applied Science at the UNH 2013

• Assertiveness Skills for Managers at Rockhurst University Continuing Education Center 2012

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