Project Manager Medical Device

Armand "Chuck" Frigon

** ******** *****, **********, ** 12804 ( H 518-***-****, C 518-***-**** (

********@**********.***

SUMMARY

Results-oriented professional with extensive experience in plant

management, materials management, operations and engineering in the medical

device industry. My background includes over 25 years of manufacturing

management experience with increased levels of responsibility. This

includes positions in industrial engineering, logistics, purchasing,

production planning, safety compliance (EHS), production supervision,

facility maintenance and operations budgeting. I've been responsible for

operations P&L, lean manufacturing programs, facility design, facility

closure and relocation as well as R&D product development.

. Logistic, Purchasing & Inventory Management

. Budget Responsibility-Capital, Cost Reduction & Overhead

. Safety & Environmental Accountability

. Regulatory Agencies-FDA, EPA, DEC, OSHA, DOL

. ISO 11135, ISO 13485

. Corrective & Preventive Action-CAPA

. Facility Design & Layout

. Equipment Automation

. Lean Manufacturing

. Employee Involvement

. Management by Objectives

.

WORK EXPERIENCE

Delcath Systems, Inc. Queensbury, NY

2009-2012

Start-up drug/medical device

VP of Operations

STERIGENICS INTERNATIONAL, Queensbury, NY

2007-

2009

Ethylene Oxide gas sterilization

General Manager

TYCO HEALTHCARE (formerly Sherwood Medical Ind.), Argyle, NY 1988-

2005

Disposable medical devices

Materials Manager for both manufacturing plants

Site Project Manager for Plant closure (January, 2004 - March, 2005)

MALLINCKRODT ANESTHESIA PRODUCTS, Argyle, NY 1983-1988

Disposable medical devices

Production and Inventory Control Manager (1985 -1988)

Senior Industrial Engineer (1983-1985)

EDUCATION

Bachelor of Science, Operations Management, Excelsior College; Albany, NY

PROFESSIONAL DEVELOPMENT

. Previous APICS Certification

. Giombetti Management & Leadership Program

. Delta Stratagem: Lean Management and Lean Manufacturing Seminar

. NYU: The Effective Engineering Manager

. University of Pennsylvania: Fundamentals of Finance and Accounting for

the Non-Financial Executive

. American Home Products: Principles of Value Analysis

. MTM Association for Standards and Research: MTM - 2B

SELECTED ACCOMPLISHMENTS

PROBLEM SOLVING

Managed the increase in business from current high volume customers along

with the addition of 16 new customers while increasing profit.

. Sales increased over 2 years by 20%

. Increased profit as a % of net sales by 1.10%

Extremely competitive marketplace for maturing commodity product lines,

narrowing, margins and critical cost positions. Developed and implemented

ongoing self-evaluation process to identify cost improvement opportunities,

particularly through the reduction in inventory investment and the

utilization of vendor managed inventories.

. Improved inventory turns by 20%, reduced inventory investment by 25% and

reduced product lead times by 30% through the implementation of lean

manufacturing principles.

ORGANIZATION

Managed operations including P&L responsibility, quality, employee

relations, training, safety, purchasing, project management and customer

service.

. Managed operational growth, 42% increase in volume over 2.5 years.

. Increased number of employees by 44%

. Reduced operational costs by 35.5%

Manage the plant closure and relocation of 30 production lines, over 600

finished good product lines, from up-state New York to Tijuana, Mexico.

Facility to be closed was unionized and employed 350 people operating on a

3 shift / 7seven day per week schedule.

. Successfully completed the 24-month project in 18 months with all

production lines up and running.

PROACTIVE PLANNING

Managed the construction of a new/start-up medical device manufacturing

facility which included a pharmaceutical laboratory.

. Directed the renovation of an 8,000 sq. ft. warehouse into a cGMP

compliant medical device manufacturing facility with a pharmaceutical

laboratory.

. Managed the layout, installation and validation of all production

equipment.

. Managed the initial staffing of R&D and Manufacturing Engineers,

Human Resource Director, and Production Workforce.

. Identified raw material suppliers and the purchase of all raw

materials for initial product manufacture.

. Established contracts with approved raw material suppliers.

. Established contracts with service and maintenance supply vendors.

. Identified and purchased ERP software system.

Implemented improvements to operational equipment and warehouse storage to

service additional volumes and customer processing requirements.

. Equipped additional sterilization chambers for parametric cycles.

. Increased warehouse storage capacity by 30% through the addition of

warehouse racking.

The manufacturing plant that I was associated with had implemented a

business management software program (IBM-MAPICS). This system was capable

of supporting the financial tracking and reporting requirements along with

inventory management, production scheduling and purchasing functions. The

system was heavily modified over time and eventually became ineffective and

could not support the needs of the business.

. As project manager, I was able to organize and manage a project team that

eliminated the need for the system modifications and which allowed us to

effectively utilize the software system as designed. This transition

required procedure changes and user training, all of which were executed

by the project team.

LEADERSHIP

Introduced the setting of goals for all elements of the quality system.

Established weekly staff meetings to review safety, quality, operational

performance, maintenance schedules, customer service issues and general

issues.

COMMUNICATIONS and PLANNING/IMPLEMENTATION

Semi-weekly operational meetings were being held to communicate the status

plant operations. Management team members were not required to attend so

minimal importance was placed on assignments/projects identified at these

meetings. Individuals were not held accountable for the timely completion

of these assignments/projects.

. Meeting agenda was revised so that individual departments each had an

opportunity to present their issues. Representation from each department

was required at each meeting. Completion dates for assignments/projects

were documented and updated.

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