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Engineer Medical

Location:
Rochester, MI
Posted:
January 06, 2020

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Resume:

Justin Donajkowski

**** ***** **** **. **********, MI 48462

Cell: 248-***-****

ada77d@r.postjobfree.com

EDUCATION:

Master of Business Administration – September 2018

Walsh College, Troy MI

Bachelor of Science in Mechanical Engineering, April 2013

Oakland University, Rochester MI

*Member of the Formula SAE Team

Associates of Applied Science in Computer-Aided Design & Engineering, May 2008

Oakland Community College, Auburn Hills MI

*Completed numerous automotive and diesel technical repair classes

*Dean’s List, 4 consecutive semesters

Certificate in Automotive Technology, May 2004

Oakland Schools Technical Campus, Pontiac MI

TECHNICAL SKILLS:

Business Management

Regulation Compliance

DVP&R, PFMEA Experience

Medical Device Process Validation

Business Management

Rebuild Race Engines

Medical Device Process Validation

WORK HISTORY:

ROMD– Rochester Hills, MI

December 2018 – Present

Manufacturing Engineer

Maintain a quality plan and initiate changes in compliance with FDA regulations for medical device manufacturing.

CAD/CAM programming and setup/operation of new contract manufacturing purchase orders

Determine the root cause for medical devices returning from the field.

Oversite operation and maintenance of the production equipment and manufacturing processes.

FCA– Auburn Hills, MI

April 2016 – December 2018

Sr. Manual Transmission Development Engineer

Plan, initiate and track engineering design projects related to transmission drivelines.

Develop, validate, and initiate design improvements.

Determine root cause and make corrective action recommendations.

Automotive CAN diagnostic (CANalyzer/CANape) and data acquisition experience.

Coordinate DVP&R testing and analysis.

Provide technical direction to CAD designers, manufacturing, release engineers, suppliers, purchasing, analysis & test engineers, as well as other product engineers.

Royal Oak Medical Devices – Rochester Hills, MI

August 2012 – May 2016

Sr. Production Engineer

Model lumbar fusion implants and surgical instruments in Solidworks.

Create detailed drawings, fixtures, and assemblies for manufacturing.

Develop an FDA approved manufacturing process and quality plan to manufacture implantable medical devices.

Develop manufacturing processes qualification standards for ISO 13485 approval.

Six Sigma and Lean Manufacturing training and experience

CNC programing of Swiss milling and turning centers to manufacture medical implants using Gibbs CAM and Partmaker CAM software.

Perform quality inspection and documentation of medical products throughout the manufacturing process to check specified part conformances.

Collaborate the development of a minimally invasive spinal fusion implant and accompanying surgical instruments.

Responsible for part design, product testing, and manufacturing of medical devices.

Created equipment validations and record-keeping, as well as preventive and routine maintenance documentation.

Chrysler LLC. - Auburn Hills, MI

Summer 2012

Product Release Engineer

Mechanical Engineering Intern during the summer of 2012.

Developed DVP&R test plan for exhaust cost reductions.

Coordinated validation testing with suppliers, and implemented changes.

Reported directly to Chrysler engineers and management for mentoring.

Gained understanding and experience of exhaust system development and tuning devices.

Gibbs Technologies - Auburn Hills, MI

Fall 2011 - Summer 2012

Mechanical Engineering Co-op

Preformed material testing on various high strength fasteners and composites.

Developed guidance manual for designing amphibious vehicle subsystems.

Performed cost analysis research on future material testing equipment.

SUMMARY:

Spirted Engineer and Business leader with a passion for excellence. Extensive hands-on experience in the medical device industry as well as automotive. Race motocross around the country as well as local automotive racing. Obtained an MBA to lay a foundation for starting an entrepreneurial business opportunity.

TECHNICAL SKILLS:

Formula SAE team member at Oakland University.

Medical Device Manufacturing

ISO 13485 & FDA conformance

Solidworks Certified Associate.

Solidworks, Catia V5, Unigraphics/NX, Gibbs Cam, AutoCAD, and Partmaker experience.

Experience with HAAS, STAR and Willamin 5 & 6 axis CNC, Mills, Lathes as well as experienced Mig and Tig welder.



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