Manufacturing Engineer II Resume Raynham, MA - Hire IT People

Areas of Expertise

6 Sigma Black Belt(certification in progress), Spanish (fluent), Portuguese (proficient), OSHA Certified
Advanced working knowledge of: Minitab, SolidWorks, MATLAB, LabVIEW, C/C++

PROFESSIONAL EXPERIENCE

Confidential, Raynham, MA

Manufacturing Engineer II

Responsibilities:

Collaborated in product design of and led manufacturing process development for product families that generate $100M in annual revenue using Design for Excellence (DFx) principles
Created engineering drawings for 17 commercial products and 100 components using principles
Reduced assembly time by 83% for a medical device component by working with an external supplier to build a specialized semi - automated manufacturing equipment
Worked with about a dozen OEMs to source medical device components
Achieved greater than 99% yield and remained below COGs limit on 100% of projects using 6 Sigma principles
Ensured quality assurance/control of successful on-time launches of three product families through supervision of engineering, verification, and validation builds at domestic and international manufacturing facilities
Used project management skills to develop a manufacturing blueprint that included process flow, equipment design, implementation of schedules and validation plans for medical implants
Awarded company Encore Award for “overcoming daunting RigidLoop Adjustable technical obstacles” and delivering manufacturing equipment and fixtures nearly two months ahead of schedule
Evaluate and work with external suppliers to develop process capable (Cpk & Ppk of 1.33) manufacturing methods for production components used in dozens of commercial finished goods
Own operations and manufacturing process from concept development through commercialization phase to ensure mass production process capability
Work on legacy and base business process changes and improvements due to unforeseen customer complaints and manufacturing defects
Work collaboratively with a core team of, manufacturing, supply chain management, quality, molding, regulatory affairs, strategic marketing, and commercial marketing professionals

Confidential, Framingham, MA

Senior Manufacturing Technician

Responsibilities:

Optimized process and manufactured purified protein Fabrazyme in a cGMP environment
Authored complex new standard operating procedures and revised current standard operating procedures
Led daily improvement of purification operations to reduce cycle time from 30 to 14 days using lean manufacturing techniques
Prepared, packed, qualified, and operated large scale ion exchange chromatography systems and TFF operations, and buffer preparation operations
Used manufacturing control systems to monitor process performance and product quality data on a daily basis
Performed internal and external audits of various departments to develop and promote best practices
Collaborated with Validation Engineering and Process Engineering departments on validation and improvement initiatives
Worked with vendors concerning troubleshooting, repair and ordering of spare parts relevant to manufacturing equipment
Trained team members and new employees as needed. Experienced with FDA, and other, regulatory audits.
Performed preventative maintenance, general maintenance, and repair as required on manufacturing equipment to ensure equipment is operating optimally
Troubleshot mechanical operations
Tracked and maintained sufficient inventories of raw and intermediate materials to meet production timelines

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Manufacturing Engineer Ii Resume

Raynham, MA

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