Denis Shannon Unrein

(Currently residing in Sahuarita, AZ)

520-***-**** (H), 520-***-**** (C), acuiko@r.postjobfree.com

SENIOR MANAGEMENT EXECUTIVE

Accomplished leader and executive with 25 years of progressive, international experience in General Management, multi-site Operations Management, Quality Management, Operational Excellence and Multi-Year Strat Plans. Industry focus centered around highly regulated medical device, pharmaceutical, and food manufacturing; with both large multi-billion dollar companies as well as rapidly growing, smaller organizations. Extensive international experience (including ex-pat) in Europe (Germany, Italy, Netherlands), Mexico, Central America, China, and the Americas. Team builder capable of aligning vision, goals, and initiatives delivering improved bottom line results. Seeking an executive management position in an organization seeking a team player with demonstrated leadership, creative problem solving, good communication skills, and strong personal drive.

SELECT QUALIFICATIONS:

Strategic Operations Planning

Certified Project/Program Management

Budget Accountability > $250M

Multi-business/Division Accountability

Certified Process Excellence Black Belt

Medical Device cGMP/QSR

Six Sigma, Certified Lean Manufacturing

Contract Manufacturing Responsibility

FDA, OSHA, OHSAS, ISO, USDA proficient

High & Low Volume Manufacturing

Large CAPEX accountability $350M

Quality Assurance Management

Mistake-Proofing Implementations

Major Multi-site re-organizations

Scale ups & Turn-Arounds

Procedures/Policy writing

Senior Level (CEO) Communication skills

Start-up Manufacturing

Strategic Metric Development

Technical Leader (engineering)

ERP experience (SAP, JDE, Oracle)

EDUCATION:

University of South Florida, Tampa, FL

Executive Masters in Business Administration (GPA 4.0), 2001

University of Kansas, Lawrence, KS

Bachelor of Science, Business Administration (Int'l Marketing & Finance) (GPA 3.8), 1991

EXPERIENCE:

BARD (Formerly CR. Bard, Inc) 2014 - 2016

Founded in 1907, BARD is a leading multi-national manufacturer of medical devices, with over 14,000 employees globally.

Vice President of Operations

Direct operational responsibility of 110 exempts and 2258 wage associates, across 3 plants/3 OEMs across 5 distinct Business Units. Site responsibility for all functions including Manufacturing, Materials Management, Distribution, New Product Introduction, Strategic Sourcing, Process Excellence, Plant Engineering, Human Resources, Finance, and Quality Assurance functions for the Nogales, MX site.

Key Accomplishments:

Developed 2 year operations strategy for turn-around performance and Strat Plan for 40-year legacy product line.

Restructured failing site KPIs; drove new A3 metric system.

Total turn-around of site performance in 2 years; Quality, Service and Cost.

Started 1st BARD Lean program that will deliver $54M for the organization in 4 years. One of the largest programs ever in the history of the company.

Restructured inventory goals; improved service over previous year by 60%.

Developed new CIP process to deliver 79 basis points to bottom line.

Exceeded PPV goal by 10%, while previous 5 years goal was missed.

Launched 3 new products; one is a market leader (SureStep Tray) that added $64M growth in revenue.

Implemented new Quality Plan to include new tools like Human Error Reduction, SPC controls, Mistake Proofing, CCP, Simplification through 5S and rest of BARD organization is adopting.

Develop OEM (Conod) to manufacture drainage bags to support growth in sales.

Manage multiple injection molding contract manufacturers that support BARD urinary products: Meters, Containers, Catheters throughout southwest US.

Developed new outside manufacturer to produce home use Vonco catheter devices plus NPD introduction of anti-odor bag for SMS product line.

Johnson & Johnson Company 2000 - 2014

WW Manufacturing Director Vision Care, 2013 - 2014

WW Engineering Cluster Director (BWI/Cordis/EES/Vision Care), 2011- 2013

Site General Manager (Juarez, Mexico & Irwindale, CA sites), 2009 - 2011

Site General Manager (Roden, Netherlands), 2006 - 2010

Key Accomplishments (Vision Care):

1st 7 year Manufacturing Strategy for organization; including a 33% expansion strategy for capacity.

Exceeding IPC (continuous improvement program) efficiency commitments by 30% (50MM additional lenses).

Approval of capital investment strategy for next 7 years.

6 new highly automated production lines at a cost of $300M.

Implementation of new Operations Governance process.

RACI improvements within PLAN organization and S&OP process.

Process Capability improvement program; reduced quality/service risks.

Improved service rates by 2 percentage points; best ever for Moist family (1.6B/yr).

Non-conformance reduction by 70%.

1st franchise CI program and culture change: IPC/Lean/ME2.

Improved 5 pts on Employee Engagement score on Credo Survey (95% vs. 90% positive response)

Key Accomplishments (Cluster Engineering Director):

New WW Engineering operational model = 15% efficiency gained.

Deployment of new Campus engineering workstream organization (CIP, Sustaining, LMS, and Technology).

Delivered $22MM in CIP savings for 2011.

Site operations IE model that was utilized across MD&D to standardize spans of control (10%-20% efficiency gains).

Engineering Lead for MD&D organization re-design effort.

Built Tooling Strategy, collaborating with remaining MD&D clusters for roll-out.

Centralized key maintenance functions (WP&C, ME2 deployment, PMs), Facilities, & Sourcing MRO across Juarez campus.

BCP program for largest Diagnostic catheter business in the world at bottleneck process (Braiding).

Obtained $28MM in CIP savings for 2012.

Obtained thru negotiations, additional new business to leverage technologies at the Juarez Campus: ie. Acclarent, Greatbatch, Incraft = $500MM+ Sales.

SEI program with four significant suppliers: Tessy, MicroStamp, Accellent, Zeus.

Developed MD&D's CoE concept in Labeling.

Transferred and launched Carto-3 system for electrophysiology business. 3D Mapping and ablation technologies.

Launched Smartblate system and multiple other generators.

Started 1st Juarez R&D Engineering pilot program with Cardiovascular Care BU.

Made connection to local Academia and Clinical partners (UTEP & Texas Tech).

Developed for WW MD&D QE2 program the Leadership, Engagement, Culture playbook for Accountability & Expectations.

Drove service improvement from 95% to over 99%; at target (99.4% all brands) first time for business in the last 7 years.

Key Accomplishments (General Manager US/MX):

Developed 5-year Strat Plan to create new space for expansion, operation team development of new skills, and alignment of organization to reduce OH costs.

New organization structure & site development program (reduced by 20% on OH).

Transfer of $300 million business to CdM site.

Implementation of company-wide All Director’s Communication meetings.

New leadership team to lead the largest MD&D plant in J&J (3 directors hired).

Increased campus annual savings by 100% (from $450k to $1MM) in 1st year.

Re-organized Juarez campus leadership team and developed new strategy/goals.

Productivity at $35.2MM (vs. previous year at $4MM), spending below goal by $3.5MM, inventory

below goal $13MM.

Consolidation plan between Cordis & BWI operating companies (saved > $800k).

Achieved highest J&J company rating for both Lean (Integrator) and Manufacturing Maintenance Excellence (Performer); Best Plant in J&J.

Supply Chain Mgt/Operations cross-functional project to meet 100 DOS target ($25MM FGI reduction).

Decreased cost per units for each product family by an average of 10% in the 1st year & average of 15% in the 2nd year.

Largest CIP implementation of all Operation sites within J&J at $30MM in 2010.

2nd year CIP implementation is $22.2MM for 2011.

Key note speaker at European Manufacturing Summit on Operational Excellence.

Employee Engagement and Do It Right Compliance Behavior programs; quality indicators across the board improved 50%.

Integrated 3rd company within the J&J Salvarcar operational facility; Codman.

Achieved favorable CNIS ($6MM) & Spending reductions of $2MM for 2010 after obtaining CIP’s of $30.2MM.

Collaborative effort with J&J franchise Acclarent on development/manufacturing of nasal passage balloons.

Key Accomplishments (General Manager Europe):

Developed New Product Strategy for non-DES product lines that launched seven new products to sustain sales.

Move of entire operations into a new state of the art cleanroom facility.

Implementation of major modifications to cleanroom facilities including HVAC, construction of air flows, monitoring systems, etc.

FDA QSIT and ISO 13485 audits with zero noncompliance observations of site.

New products in Endovascular including joint venture with EES; esophageal catheter and pill camera for internal x-ray process.

New products in CVT business with sales potential of $32 million.

Drove an 8% drop in cost per unit (86€ vs. 95€) from ’06 to ’07.

Develop operations and financial information to place site up for sale.

Site Strategy based upon leveraged OH and Tax Optimization, which led to bottom line incremental increase of $13 million.

Re-structure of NPD organization to streamline new product launch process and leverage existing OPS organization (Aviator + program).

Development of external network in The Netherlands to obtain support and subsidies for major innovation projects.

Built WW COE of Manufacturing System Design/Build organization.

Continued operations productivity of $13.5 million in leveraged fixed cost (even with a decline in volume by 60% at the site).

Implement two major external manufacturer contracts for PTCA and PTA markets.

Continued operational efficiency improvement of 30% over ’06 and greater than 50% reduction in quality failures (product nonconformities) over ’06.

Increase in operating income by 12% ($9.5M) even with a decrease in sales of 16.3% from 2006 to 2007.

Negotiation (with Unions, Works Council, & Supervisory Board) for shutdown of a major operational/R&D facility without incidents or strike in Europe.

Implementation of shutdown strategy of European site on schedule.

Operations Director (Roden, Netherlands), 2005 to 2006

Operations Director (Miami Lakes, FL), 2004 to 2005

Business Unit Manager, PE/Lean Core Director (Miami Lakes, FL), 2002 - 2004

Manufacturing Manager (Miami Lakes, FL), 2000 - 2002

Key Accomplishments:

Led Operational Strategies for multiple new component introductions.

Completed multiple lean projects with total savings of $4.4 million.

Recruited and developed new extrusion management team; 3 sups 4 engs.

Construct new extrusion facility at 50,000 square feet at a budget of $11 million.

Developed strategy for operational move between site buildings (147 machines).

7% - 21% range of efficiency improvement across all lean manufacturing lines.

80% reduction in quality failures in Operations.

Development of eight new high performance associates to exempt team.

Implementation and development of new cross-functional PET/MRB org structure.

100% Performance to Schedule for catheter delivery system lines (CP2 process).

Cost savings of $10.8 million in 2 years; achieving cost per unit savings of 13%.

Productivity of $21 million in leveraged fixed cost (a 200% improved year).

Improved customer Line-fill rates by 5 percentage points (97% vs. 92%).

Implementations of best-in-class process technologies like SMED sealing machines, Poka-Yoke quality devices, reduced foot-print line designs.

12% productivity increase in PTCA/SDS (Worldclass goal of 95% targeted).

Lean Grinding cell at savings of $250,000/annually.

SMED project in Extrusion; setup reduction of 50%.

Lean Return Goods Line at an efficiency improvement of 67%.

Yield improvements obtained in Balloons at 8% above BP.

Four completed Process Excellence projects with total savings of $16.9 million.

Yield improvement from 67% to 92%.

Improved customer service by over 25%.

Reduced unit cost by 49% by efficiency and Six Sigma projects.

Led the most successful operations FDA audit in Cordis’ 25 years.

Completed three major operational transfers.

Led consolidation efforts of component manufacturing to create a CoE.

Reduction of quality discrepancies by over 80%.

Bausch & Lomb 1995 - 2000

Project/Validation Manager (Sarasota, FL), 1999 - 2000

Y2K Project Manager (Sarasota, FL), 1998 - 2000

Manufacturing Supervisor (Sarasota, FL), 1995 - 1998

Key Accomplishments:

Continuous flow process re-design, cleanroom packaging implementation, and polymer material variability improvements.

Redesigned site’s validation system (procedural changes) and created protocol/report formats.

Led transfer of quality test lab processes from Clearwater facility to Sarasota facility

Training traceability software system to improve compliance to QSR.

Lean Hefilcon Wet inspection and packaging operation = $1.5 million in savings and improved throughput by over 90%

Improve accuracy of software forecasting system, resulted in reduced backorders and reduced WIP.

Eliminated all potential opportunities for failure due to 2000 date change, > 700 systems remediated.

Organized Y2K teams in sister facilities in Tampa and Clearwater.

Member of B&L Corporate Y2K Remediation Team.

25% increase in production capacity in inspection/packaging department.

80% decrease in documentation and process errors in dry manufacturing.

Certified as an ISO Lead Auditor with British Standards Institute (BSI).

Initiated software capacity model for all departments for budgeting purposes.

90% improvement in throughput in the Ultrasonic Cleaning operation.

Remel L.P. 1993 - 1995

Manufacturing Supervisor (Lenexa, KS)

Hormel Foods Corporation 1991 - 1993

Production Supervisor (Fremont, NE)

Excellent references upon request

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