Kevin Riley Vadnais Heights, Minnesota 55127

Mobile 612.965.0508 E-mail kriley9297@yahoo.com

OPERATIONS MANAGER

QUALIFICATIONS PROFILE

Results and performance-driven Operations Manager with extensive production and manufacturing management history

and demonstrated Kaizen Lean Manufacturing and Six Sigma process implementation expertise. Versatile process

innovator with track record for implementing/optimizing workflow, production, and compliance processes, increasing

enterprise-wide efficiencies, and reducing operating expense. Inspirational team leader, trainer, and mentor credited with

training and directing high-performing technical service teams, facilitating enterprise-wide transitions, minimizing

downtime, and improving production quality, service delivery, and profitability. Medical industry subject matter expert

with impressive emphasis on accountability, process innovation, and performance excellence.

CORE COMPETENCIES

Production Maintenance Team Training, Development, and Performance Management

Production Scheduling, Forecasting, & Planning, FDA, SSR, ISO, GMP Regulatory Compliance

Kaizen Lean Manufacturing & Six Sigma Process Implementation, Continuous Process Improvements

Quality Management, Strategic Planning, System Transitions, Risk Management

New Production Facility Launches, Plant Layouts & Implementation

Production Reporting & Root Cause Analysis, Resource Management/Allocation

MS Word, MS Excel, MS PowerPoint, MS Project, Minitab, Windchill, Infor, SAP, Great Plains

PROFESSIONAL EXPERIENCE

ST. JUDE MEDICAL (Endocardial Solutions), St. Paul, Minnesota, Minnesota, Jan 1998 – Dec 2015

Manufacturing Technical Services Manager/Equipment Maintenance Sr. Supervisor, Feb 2011 – Dec 2015

Recruiting, training, and directing 12 technicians, overseeing campus-wide technical maintenance of multi-

million-dollar production equipment inventory, and driving the daily production of thousands of medical

devices.

Coordinated relocation of St. Paul to Minnetonka Array catheter manufacturing operation,

developed/executed build plan, strategized workstation layout and utility drops, ramped up production line,

and facilitated a seamless operational transition.

Scheduled first and second-shift personnel, optimized labor utilization, and assured timely completion of

preventative/unscheduled maintenance of 3500 tools, fixtures, and equipment in four campus buildings. Monitored team production performance, assured safety procedural compliance, achieved/sustained

accident-free work environment, and mitigated corporate liability and risk.

Leveraged scheduling software tools, implemented task schedules and durations, improved workflow

efficiencies, and advanced on-time performance from 90 to 99.9%.

Interfaced with internal auditors, identified procedural production issues and challenges, and

developed/implemented corrective action plans.

Conducted root-cause analysis, identified repetitive equipment breakdown causes, streamlined/improved

equipment maintenance procedures, reduced labor demand, maximized equipment reliability, and

minimized downtime.

Developed/executed Maintenance Department Annual Operating Plan, and achieved forecasting and

budget compliance.

Facilitated campus-wide conversion of Calibration Manager to Infor EAM maintenance software system,

and improved technical team information sharing and accessibility.

Trained and technically supported engineers and technicians on EAM software system and increased team

competency and proficiency.

Wrote engineering rationales and reported the impact of out-of-tolerance calibration incidents.

Collaborated with Operations, Quality, Microbiology, and Facility Departments, coordinated numerous

facility equipment transfers, installations, and upgrades, and increased production quality and

productivity.

Kevin Riley Page Two

PROFESSIONAL EXPERIENCE

ST. JUDE MEDICAL (Endocardial Solutions), St. Paul, Minnesota, Jan 1998 – Dec 2015

Manufacturing Supervisor, Jan 1998 – Feb 2011

Oversaw production operations, directed 60-person Production Team, launched Array catheter production

line, mobilized/aligned production resources, and assured on-time production, specification, FDA, QSR,

ISO, and GMP compliance. Led continuous improvement initiatives, leveraged Lean Manufacturing, Six Sigma, and Kanban,

methodologies, and achieved yield, productivity, and lead-time objectives.

Hired full-time and temporary production employees, aligned staff resources, and consistently met catheter

build schedule demands.

Championed/instituted a second-shift operation, hired, trained, and developed shift supervisor, and

successfully accommodated increased production, schedule, and compliance demands.

Created/executed Department Operating Plan within targeted budget and forecast requirements.

Aligned catheter raw material inventory and Kanban levels, and achieved productivity and output targets.

Oversaw production staff, supervised order-fulfillment, cycle count, pick-up, and delivery processes, and

maintained inventory availability and on-time delivery.

Served as manufacturing subject matter expert, implemented Great Plains and SAP ERP systems, provided

real-time production and transaction processing information, and improved productivity/efficiency.

Conducted employee performance reviews, established individual and department goals and objectives, and

assured corporate standard policy compliance.

Led cross functional team, executed catheter manufacturing-floor re-layout project, implemented Lean

Manufacturing and Orange Belt methodologies, and reduced throughput cycle time by 23%.

Designed/enhanced production fixtures, and reduced process variability, improved throughput time and

ergonomic efficiencies.

Created/detailed engineering change orders, updated manufacturing processes, and increased efficiencies,

yields, and regulatory compliance.

Detailed engineering rationales and initiated Non-Conforming Materials decisions and corrective action

plans.

Addressed production audit issues, initiated Catheter Manufacturing remedial and long-term action plans,

and reported results in CAPA Board and Quality Management Review meetings.

Represented Catheter Manufacturing Department during ISO, FDA, and external audits, led production

area tours, presented production related documentation to external auditors, and achieved audit compliance.

EDUCATION

UNIVERSITY OF MINNESOTA, Twin Cities, Minnesota

Bachelor of Arts Degree, Biology & Psychology

Minor: Chemistry

PROFESSIONAL DEVELOPMENT HIGHLIGHTS

Supervision Training Program, Employers Association

AAMI Quality System Requirements and Industry Practice

Six Sigma Green Belt Training, St. Jude Medical

Infor EAM Site Manager Level Training, St. Jude Medical

Situational Leadership, St. Jude Medical

The Adaptive Manager, St. Jude Medical