Daniel Coughlin Email & Phone Number

Minneapolis, Minnesota, United States

København, Capital Region, Denmark

• First manufacturing engineer hired for novel freeze-dried plasma product nearing FDA approval. Owner of manufacturing process, manufacturing layout and reporting manufacturing readiness to senior management.
• Analyzed forecasted demand versus projected capacity and proposed solutions to larger team
• Utilized creative thinking to generate a simple manufacturing change which will increase capacity by 20%
• Authored manufacturing procedure and reduced opportunities for error in batch record by over 500%
• Represented manufacturing perspective during review of product and process designs with R&D engineers
• Subject matter expert for manufacturing process, calibration, and facility requirements during FDA Pre-Approval Inspection

• Primary engineering support for coil winding and braiding operations. Responsible for improving capacity and maintaining quality.
• Increased capacity on braiding line by 179% and coiling line by 159% to meet surging demand
• Reduced non-conformance rate on braiding operation from a rate of 28 nonconformances/year to 1/year
• Completed Lean Six Sigma Green Belt Certification o Delivered savings of $120,000 through reduction of inventory levels while also reducing lead time through work center
• Direct supervisor to 4 coil winding operatorso Promoted team work, respect, and accountability within team o Involved production operators on continuous improvement projects to ensure their ideas were heardo Prepared.

• Primary engineering support for coil winding and braiding operations. Responsible for improving capacity and maintaining quality.
• Increased capacity on braiding line by 179% and coiling line by 159% to meet surging demand
• Reduced non-conformance rate on braiding operation from a rate of 28 nonconformances/year to 1/year
• Completed Lean Six Sigma Green Belt Certification o Delivered savings of $120,000 through reduction of inventory levels while also reducing lead time through work center
• Direct supervisor to 4 coil winding operatorso Promoted team work, respect, and accountability within team o Involved production operators on continuous improvement projects to ensure their ideas were heardo Prepared.

Maple Grove, MN

• Primary quality representative for multiple product lines including extraction catheters, ultrasound vascular access, and catheter component services. Gained valuable experience with all aspects of product lifecycle.
• Balanced time to meet the needs of new product development, production floor, and incoming component inspection
• Led CAPA and Non Conforming Event investigations to determine the root cause
• Given responsibility of training new hire. Monitored overall workload and managed prioritization of projects

• Highly competitive rotational program through quality engineering, process development and manufacturing engineering.
• Provided manufacturing support during testing and initial builds of two products in development
• Managed operational qualification builds and testing of new product under development

Nicaragua

Studied Spanish and technical skills on medical equipment repair while living abroad in Nicaragua.Worked for one month in a hospital in rural Nicaragua repairing broken medical equipment.

Bachelors, Biomedical Engineering

Master Of Business Administration (M.B.A.)

Mayo Innovation Scholars Program o One of six MBA students selected to participate in unique experiential learning opportunity within the.