Pat Cullinane Email & Phone Number

County Galway, Ireland

Ireland

Independent Consultant with 20 years of experience in Medical Device & Pharmaceuticals. 16 years of experience delivering business process improvements, utilising Lean, Six Sigma and Change Management in Western & Central Europe, India, Ireland, USA, Canada, Mexico and Puerto Rico. Sectors: Pharmaceutical, Medical Device, Engineering, Public Service, Customer Service Centres, Publishing, Printing and Plastics

Ireland

Principal Consultant with subject matter expertise in the areas of Global Project Management and Operational Excellence (specifically lean/six sigma)

County Galway, Ireland

Ireland

Ireland

Supporting 6 Sites/Locations and the local Operational Excellence teamsLeading, mentoring and facilitating projects in:Manufacturing, Global Supply Chain, Regulatory Affairs, Labeling & Artwork, Quality, Laboratories, Procurement, Strategic Sourcing, Process Development and Site Expansion Lean Design.

Supported targeted projects in Customer Services, Operations & Marketing to improve quality, reduce turn-around times and cost.Developed & Rolled Out Lean Six Sigma Program worldwide Supporting 7 Locations/Operations in EMEA & APAC, 9 Operations Divisions and 2 Marketing GroupsCoaching and Mentoring 35+ Belts in EMEA & APAC.Conducted multiple “end to end” Enterprise level Value Stream Mapping projects, involving engagement of Operations and MarketingImplemented Intranet Portal for Communication and Project Tracking

Responsible for 3 sites in the UK & IrelandDeveloped financial analysis methodology for project selectionRecognized divisional (20 sites) “Most Improved Lean Six-Sigma Site” 2008 Led European Inventory Reduction / Supply Chain project. 5 sites Responsible for project selection, mentoring and project execution

Only Lean Expert working in the office environment. This involved 21 days of technical and soft skills training throughout 2006.Implemented site lead model, in Office Lean, using Standard Work and Lean Metrics. Over 6 months this project resulted in a reduction in WIP and Rework of 50%.Supervised and mentored a team of 18 software validation engineers as part of the Equipment Engineering Group.Responsible for automated equipment software validations in 2 of the 7 product families at the facility.

Managed the Quality, Microbiology and Sterilization (On-site ETO) department of 37 people, at a 770-person site with Class I, II and III medical devices.Led teams to eliminate the root causes of 8 out of the top 10 complaints.Implemented lead model in process validation using six sigma principles.Led team to successful NSAI surveillance audit to ISO 13485

Solely Responsible for Mentoring and Supporting 31 facilities in conducting process validations utilizing Six-Sigma tools. This included facilitating execution at the local facilities, whose businesses included Medical Device, Pharmaceutical, Imaging and Retail.Conducted Six-Sigma Validation training for 500 employees worldwide. (USA, Canada, Mexico, Puerto Rico, Ireland).3 Day hands on training course covering Process Map, C&E, FMEA, Gauge R&R, DOE and RSM.

Certified Six Sigma Black Belt by Tyco and Lean Manufacturing Expert by University of Kentucky (Toyota affiliated)Managed Projects producing cost savings of $522k (Six Sigma & Lean)Actively participated in small teams, producing cost savings of $2,310k (Six Sigma & Lean)Led teams to track, trend and improve yields, rework, scrap and customer complaints, resulting in receiving Respiratory Division’s Presidents Award for customer complaint reduction.

Conducted root cause investigations, identifying solutions and implementing corrective and preventative actions for supplier quality issues.Assured vendor quality of all purchased machined components for Class III & II devices. This included generating and maintaining incoming inspection procedures.Selected and audited suppliers as lead auditor, and conducted supplier reviews.

Advanced Project Management

The Stanford Advanced Project Management Certificate Program provides professionals with advanced tools and techniques to strategically.

Lean Six Sigma Master Black Belt

The training program covers the Master Black Belt body of knowledge and topics ranging from advanced DOE to Leading Change to Finance.

Change Management Certified Program, Certified

Lean Systems Certification

3 week-long sessions delivered over 3 months, with exams and project required for certification.

Beng, Mechanical & Manufacturing Engineering

Activities and Societies: Head of Mechanical & Manufacturing Society, Secretary of Saint Vincent DePaul Society, Founder & Secretary.

Education record