SUMMARY

• 8 years of experience as a Manufacturing Engineer in a contract engineering company specializing in medical device manufacturing, 1 year of experience as a Manufacturing Engineer in a drug packaging startup, 2 years of experience as lead engineer in a focus factory at a high - volume syringe plant, currently working as a production engineer automating manufacturing of marine lighting.
• Experience includes automation design and improvement, new product introduction, validations, high volume/low mix and low volume/high mix production.

AREAS OF EXPERTISE

• Manufacturing Automation Design and Improvement
• SolidWorks/AutoCAD
• PLC Programming/Ladder Logic
• HMI Programming
• Industrial Electronics
• RoHs and WEE
• New product introductions (NPI)
• Design for manufacturability review (DFM)
• PCBA and Systems assembly
• DMR, DHR, QSR, GMP
• Low volume, high mix manufacturing
• High volume, low mix manufacturing
• Project management
• Class 1, 2 & 3 medical devices
• ISO 13485 /9000/ 9001 / 9002 / 14001
• CAD / Layout
• CM / ECN / MRP
• Validations (IQ/OQ/PQ)
• Corrective and Preventive Actions (CAPA)
• Failure Modes and Effects Analysis (FMEA)
• Lean Six Sigma - Black Belt Trained
• Statistical Analysis

PROFESSIONAL EXPERIENCE

Production Engineer

Confidential, Delray Beach, Florida

Responsibilities:

• Sole production/manufacturing engineer for a company producing extreme environment lighting focused on the marine market.
• Led transition of primary product lines from fully manual production to partially automated production.
• Designed and built automation cells to increase output per operator by 300% for these products.
• Developed and validated custom adhesive dispensing, inspection and vacuum installation processes.
• Transitioned multiple New Product Introductions from Engineering to Manufacturing.

Sr. Manufacturing Engineer

Confidential, Deland, Florida

Responsibilities:

• Lead engineer in a focus factory dedicated to the high-volume production of Safety Needle Assemblies.
• Area of responsibility included 5 form, fill and seal packaging lines, 3 high speed assembly machines, molding, and cannula grinding operations.
• Responsible for cost savings projects with annual savings in excess of $500,000
• Responsible for multiple quality related improvements to the automation lines to address customer complaints, CAPA’s, and non-conformances.
• Responsible for capital project to upgrade and maintain serviceability of aging automation lines

Manufacturing Engineer

Confidential, Auburn, Alabama

Responsibilities:

• Manufacturing Engineer at a start-up drug container company, which utilized a novel process to plasma coat plastic vials and syringes with a glass layer.
• Responsible for process development for part cleaning/conditioning between cycles.
• Responsible for new automation and manufacturing equipment design.
• Responsible for validating new automation and manufacturing equipment.
• Aided in setup of pilot plant and processes for clinical trial production.
• Responsible for developing and implementing multiple particulate control solutions.

Manufacturing Engineer

Confidential, Huntsville, Alabama

Responsibilities:

• Process and Manufacturing Engineering at a fast-paced contract manufacturer.
• Responsible for developing manufacturing line layout/flow and manufacturing processes for multiple varied medical devices.
• Medical device product lines ranged from printed circuit board assemblies through complex electromechanical devices such as dialysis equipment.
• Responsible for performing Manufacturing Engineering duties on multiple separate medical product lines from Prototype/Pre-Production/New Product Introduction phase through successful IQ/OQ/PQ as validation team leader.
• Authored and executed multiple Installation Qualification, Operational Qualification, and Performance Qualification Protocols and Test Reports.
• Authored multiple FMEA’s, Verification documents, engineering white papers.
• Provided Design For Manufacturability Analyses and worked with design teams to reduce cost of manufacturing through design optimization.
• Led validation team for a high volume automated line used to manufacture millions of blood glucose meters.
• Responsible for executing and documenting functional acceptance testing, Installation Qualification, Operational Qualification and Performance Qualification.
• Led improvement team for above mentioned high volume automation line where statistical analysis of product defects and machine faults was utilized to identify and prioritize machine changes and improvements to improve yield and throughput. Downtime was decreased by over 100% and yield was increased by over 15% as a result of these improvements.
• Designed and implemented tooling and fixtures as needed utilizing various CAD software tools to allow for repeatable, reliable processes on assigned programs.
• Responsible for rapid transfer of medical product from overseas plant. Customer required rapid movement of product line and production from Mexico to the US. Team successfully completed transfer and had completed final stage prototype production and validation within 6 weeks of start of project.