Profile Details

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USD 95 /hr

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Hire Alexey D.

Canada

USD 95 /hr

Manufacturing Consultant Product Development - Medical Device 15+ years of experience in manufacturing engineering

Profile Summary

Product Design - ​Design based on expertise from the manufacturing environment, we support engineering teams by providing guidance on best practices. Perform DMFEA along the design phase to prevent future failures. Process Development - From Capital Equipment selection, jig, and fixture design to process development, parameters optimization, process qualification and validation based on ISO 13485 and FDA regulations. Supply Chain Management - Suppliers selection, qualification, auditing. I help manufacturers establish long-term relationships with suppliers with a win-win approach. I simplify specification by focusing only on critical parameters which lead to lowering cost and shortening lead time. Manufacturing and Operation Support- I help manufacturers implement quality systems and risk management approaches to meet the requirements. Create SOPs, Change Control, CAPA, and WIs, and perform staff training. ​

Subject Matter Expertise

• ☆ Industrial Engineering
• ☆ Manufacturing Facility Design
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485

Services

• Consulting

Consulting Operations Consulting, Scientific and Technical Consulting, Manufacturing Consulting

Work Experience

Consultant

ALEDEM Consulting

January 2019 - Present

Manufacturing Manager

Ikomed Technologies

January 2019 - September 2021

Sr. Manufacturing Engineer

Biolux Research

April 2015 - January 2019

Education

Masters of Science - Material Science

Siberian State Industrial University - Russian Federation

September 1999 - July 2004

Certifications

• Certification details not provided.