SUMMARY:

• Superior performance in Manufacturing, Processing, Quality and Supplier Quality Engineering exceeding all product quality, service, delivery, safety, regulatory compliance and all in plant and supplier metrics cost effectively and on time.
• Highly effective relationships builder and change agent who interacts superbly with all team member levels.
• Project planning, action, doing and metric measurements use in meeting all objectives.
• CQE and ISO Lead Auditor Trained with extremely effective application in every assignment.
• In - depth experience in all aspects of many manufacturing processes including risk analysis, dFMEA, pFMEA, manual & automated assembly & test, single and progressive stamping, vertical & horizontal machining, single & multiple spindle screw machine, turning machine, tool & die manufacture, FMS, sheet metal, manual and robotic welding, Al & Zn die casting, cutting, lamination, routing, metal finishing, wet & powder paint, coatings, grinding, heat treat, powdered metal, PCB, wire harness, rotor & stator winding, plastic & metal extrusion, plastic molding, supply chain, warehouse, letter shop, pick pack ship fulfillment, sterilization, Agile creator, lean, 5S, CI, QMS, SPC, CA, CAPA, metrics, KPI, root cause analysis, statistical analysis, IQ, OQ, PQ, PM, EH&S, performance and risk analysis.
• Lead product safety risk analysis of more than 1000 products both new and existing which greatly minimized corporate risk in commercialization of these products.
• Developed and implemented extensive corporate metrics and their very effective in several companies.
• Championed of the ISO quality process into 9 facilities very quickly and cost effectively.
• Superb performance achieved in every position leading major cultural change which resulted in dramatically improved metrics in all areas.

PROFESSIONAL EXPERIENCE:

Confidential, Plymouth, MN

Senior Process Engineer

Responsibilities:

• Updated CAPAs in a broad line of medical catheters, introducers, implantable leads, pain control and micro molding.

Confidential, Egan, MN

Quality Engineering Consultant

Responsibilities:

• Developed EU submission for CE mark and improved Quality Management System in preparation for ISO Audit in development of absorbable surgical dressings for very unique control of cancellous bone bleeding.

Confidential, Plymouth, MN

Supplier Quality Engineer

Responsibilities:

• Completed review, update and close of all older SCARs effectively meeting all objectives in a broad line of medical products. Worked on a project to develop supplier Quality Assessments for new product introductions.

Confidential, Minneapolis, MN

Senior Process Engineer

Responsibilities:

• Achieved tooling and process verification and validation in sterile barrier packaging for this penile prosthetic and incontinence urology products company.

Confidential, Minnetonka, MN

Senior Quality Engineer

Responsibilities:

• Resolved NCMR and CAPA delinquencies for this spinal surgery products company while addressing day to day process issues.

Confidential, Blomington, MN

Senior Manufacturing Engineer

Responsibilities:

• Supported manufacturing operations in a wide variety of very highly technical flame and gas detection safety systems.

Confidential, MN

Manufacturing Engineer

Responsibilities:

• Completed extensive practice vs. procedure analysis and gap remediation in a custom polymer process.

Confidential, Minnetonka, MN

Manufacturing Engineer

Responsibilities:

• Analyzed and updated all manufacturing process documentation for many urological products. Developed Manufacturing Procedures and Standard Operational Procedures for processes such as Silicon Molding,
• Extrusion of kink resistance tubing, Silicon Mandrel dipping, assembly, test and others. Completed extensive practice vs procedure gap analysis and consequently gaps remediation. Completed extensive line clearance, product flow and lean manufacturing projects.

3M, St Paul, MN

Technical Services and Product Safety Risk Engineer

Responsibilities:

• Developed product safety risk assessments in support of 16 Confidential US business units and most Confidential OUS sites for a very wide variety of products. Lead cross functional teams in product review and analysis for residual safety hazards and developed corrective action to ensure acceptable product risk prior to release.

Confidential, MN

Consultant/Quality Manager/Process Engineer

Responsibilities:

• Developed and implemented many corporate metrics and lead major in each.
• Championed the ISO quality regulatory process into 9 facilities quickly and cost effectively.
• Achieved excellence in cost, quality, response time and client satisfaction.

Confidential, MN

Director of Operations

Responsibilities:

• Achieved process improvement and cost control to meet corporate metrics.

A-Plus Industries Rogers, MN

Plant Manager

Responsibilities:

• Output doubled and profitability achieved. This included hands-on manufacturing, quality and supplier quality engineering input.

Confidential, Forrest Lake, MN

Plant Manager

Responsibilities:

• Developed more effective processing and control achieving excellent internal and external metrics improvement. quality van converter rating in the industry during a period in which sales of the company tripled. This included hands-on manufacturing, quality and supplier quality engineering input.

Confidential, MN

Chief Operating Officer

Responsibilities:

• Achieved profitability in each plus achieved flexible circuit to the military standard. Included hands-on manufacturing and quality.

Confidential, LeCenter, MN

Vice President of Operations

Responsibilities:

• Achieved profitability following a 14 year loss history. This also included manufacturing and quality engineering.

Confidential, Fridley, MN

Production Manager

Responsibilities:

• Excellence achieved in quality, productivity, cost and failure reduction metrics.

Confidential, Hopkins, MN

Director of Operations

Responsibilities:

• Excellence achieved in quality, productivity, delivery, inventory reduction, employee relations and loss reduction metrics.

Confidential, Blomington, MN

Director of Quality/Director

Responsibilities:

• Achieved excellence in quality, warranty, cost effective procurement of $200 million which enable many assembly lines and 2600 personnel to achieve excellence in cost, delivery, quality and client satisfaction metrics.