HECTOR LUIS CRUZ-ORTIZ

**** ** ***** *** ***.*** 619-***-****

Pembroke Pines, Fl 33025 adtves@r.postjobfree.com

Top-performing Senior Executive Leader and Lean Six Sigma expert with broad-based experience in a variety of industries. Proven record optimizing biotechnology, pharmaceutical, medical devices, and aerospace operations and organizations. Excellent operational, strategic, and business leadership for multi-site manufacturing and service operations. Expertise in organizational development, EHS solutions, continuous improvement, and deep cultural transformation for Fortune 100 industry leaders. Successful in driving multimillion-dollar manufacturing projects to completion, building high-performance teams, and developing cross-functional collaboration strategies at all levels.

Value Offered

Licensing and Acquisitions Leads the sourcing, evaluation, and execution of transactions across the USA and Latin America. The combination of projects after the Biomet acquisition delivered over $200M in synergies.

Strategic Financial Manager & Systematic Problem Solver Turned around plant financials from an accumulated loss

against the budget of -$17MM in seven years to a strong YTD result of $130K in positive variances.

Visionary Director Leverage technology and automation to increase reliability resulting in sustainable defect-free operations.

Managed a continuous improvement journey that resulted in winning Corning's annual Best Site-Performance Award for three consecutive years.

Continuous Improvement & Lean Focused Recognized for streamlining operations to increase productivity and efficiency

without sacrificing quality. Proven record of being effective in eliminating Muda from management structures and systems improving agility and financials.

Motivational Leader Win trust at all levels of the organization from upper management to floor staff. Excel at developing

collaborative environments.

EHS and Compliance Management Strengths Promoter of behavioral-based cultures having obtained significant reductions in

safety incidents and human errors in different and diverse organizations, improving quality.

Select Career Achievements

Revenue Generation & Financials:

Delivered savings of over $11MM in waste (Muda) elimination driven by a strategic program that last three years.

Increased gross profit by $2.9M annually by improving yield, sample reductions, and process optimization.

Enabled a 45% increase in production throughput within 2 years with less than 9% in additional hiring enabling a pull

system to reduce inventory levels and triggering substantial levels of positive absorption resulting in a $27MM profit improvement YOY.

Continuous Improvement:

Developed work streams focused on a comprehensive scrap reduction program (filling components and raw materials) that

achieved monthly savings of $150K+.

Established a steering committee focused on spending control that resulted in monthly savings of $200K+ in services, stock parts,

and raw material management; laboratory reagents and standards; spare parts; and cost of compliance remediation.

Established a task force that included quality, floor operators, material handlers, technicians, engineering, and supervisors to

reduce changeover in packaging areas. The team achieved a combined activities reduction of 40%, improving change over time by 30% and efficiency by 2%.

Designed a batch record review process that resulted in a 33% lot disposition cycle time optimization.

Product Introduction & Transfer:

Led a $12M plant expansion to accommodate 48 molding machines and consolidated three-building operations into one facility to save $25M for a manufacturing company, as well as overseeing $4M in cost reduction projects and driving improvements that improved customer satisfaction to 98%

Managed the successful commissioning of manufacturing plants in Puerto Rico, the Dominican Republic, Mexico, and Texas, a combined $45M investment that created more than 5,000 jobs combined.

Completed Allergan IOL’s product transfer from Irvine, California to a new facility in Puerto Rico including facility start-

up, hiring process, training structures, operation framework, and regulatory agencies (FDA, EPA, etc.) approval for commercial operation.

Organizational Leadership:

Achieved 80% overall cross-trained flexible workforce by establishing a cross-training program in Raytheon Technologies site.

Redesigned organizational structure, increasing capacity by 15% and saving over $500K in overhead spending.

Regulatory Compliance:

Developed a strategy including focus groups to assess and address deficiencies in plant quality systems, management systems,

and compliance risk factors, resulting in the potential lifting of an FDA Warning Letter.

Managed 2 global quality standards in 6 Zimmer facilities without deviations and with 100% schedule adherence.

Developed a collaboration strategy with quality and training departments yielding 15% reduction in human error non-

conformances within 3 years.

PROFESSIONAL EXPERIENCE

General Manager-Automotive and Commercial

National Molding (NatMo) Miami, FL March 2022 - Present

Provide direction to all Automotive and Commercial businesses. Full P&L responsibility with 92 molding press and subassembly operations, marketing, and sales. Manage all new contracts and Distribution centers.

National Molding is a leader in the injection molding segment for precision parts. The company produces over 3.5 billion parts annually, utilizing highly engineered resins. National Molding’s use of cutting-edge technology supported by our proprietary injection molding process is unmatched. Hetero Cavity injection molding was developed here at National Molding and it continues to be the foundation of our manufacturing processes today.

Improved productivity by 15%

Increased Commercial market by 20%

Achieved OTD of 98%

Safety (Zero OSHA recordable)

Established a make-to-order system for the commercial market

Site Director Operations - Avionics Division

Collins Aerospace (A Raytheon Technologies Company) Melbourne, FL 2017 - 2022

Managed all Commercial Avionics, Business and Regional, Communication, Navigation, Surveillance, and Air transport. Direct responsible for 1200+ employees. Responsible for a COS of $320M with $1 billion in sales. Lead a site of 5 complex manufacturing plants and the largest electronics site in Raytheon Technologies with 5 SMT lines. Direct sales to Boeing, Airbus, Bombardier, Embraer, and other major Airlines. Responsible for operations, testing, materials, logistics, and distribution (Inbound and Outbound) of the Electronics and Mechanical Avionics products.

Improved 17% output performance

OTD average 97% (OEM, Aftermarket, and MRO)

Implementation of Shop Floor Management and SWCS as part of the OPEX/ACE program

Internal defects reduction of 17%

Established a safety program and achieved the best record of total case safety incidents

Achieved $1.1M in savings by applying Lean tools

Director Electro-Mechanical Division

UTC Aerospace System (A Raytheon Technologies Company)

Managed all Mechanical operations for the largest high-mix aerospace operation in UTAS. Direct responsible for an organization of 700+ employees, $300M in COS. In charge of four (4) complex manufacturing plants. Direct sales to Boeing, Embraer, Airbus, and other major airlines. Responsible for the commercial, distribution (Inbound and Outbound) of OEM, Interplants operations, and Military programs. Support design of dynamic mechanical and electro-mechanical components. Create engineering drawings with ANSY Y14.100 standards. Comply with AS9100D, ARP 4754, 4761. Responsible for Roadmap, financial, and project completion.

Improved productivity by 20%

Improved the OTD by 15%

Improved the cycle time by 35%

Vice President of Business Development

BEC GLOBAL INC, (Business Excellence Consulting, Inc.) USA 2017

Managed all worldwide operations including marketing and sales. Also, responsible for the expansion of BEC Global business by selling professional development experiences across various sectors and work environments, with an emphasis on businesses experiencing growth and change. Focus on training, workshops, quality systems, audits, quality remediation, project management, and more consultative custom solutions centered on leadership and organizational development.

Responsible for the commercial and distribution of all products with customers in the Pharmaceutical, Electronics, Medical Devices, and Food Industries. Lead the sourcing, evaluation, and execution of transactions in Latin America and the Caribbean.

Site General Manager Hospital Products Formulation, Filling & Packing Operation

Baxter Healthcare Corporation, PR, USA 2016

Provide direction to Baxter’s second-largest high volume/high mix IV filling manufacturing facility. Direct responsible for an organization of 1100+ employees, $150MM Budget to ensure formulation, filling, and packaging of 190M+ units annually. The operation includes premium products such as Clinimix®, Premasol®, Travasol®, Clinisol®, Heparin®, Metronidazole®, Gentamicin®, Milrinone®, Dextrose Solutions, Potassium Chloride Solutions, Fluconazole®, and Lidocaine®. Responsible for the commercial and distribution of products.

Improve the service level by 30 % and efficiency by 20 % for business operations.

Saved $1.2MM in overhead reduction and spending controls.

Drove $1MM in savings through work streams focused on defect elimination and scrap reduction.

Implemented a recognition program to improve people's morale and foster engagement in CI initiatives.

Increase production capacity by 11% (equivalent to 21M units/year).

Advanced a continuous improvement culture through visual management elements, accountability programs, initiatives for integration and communication of critical functions, and re-establishment of KPIs and measuring mechanisms.

Americas Integration Leader

Zimmer Corporation Warsaw, IN 2015-Jan 2016

Responsible for the Integration of both companies in the Americas Region. Manage the operation’s divestitures, acquisitions, supply chain, and project management. Evaluate and manage synergies in Operations, Sourcing, and Real Estate. Create and drive every Roadmap in a complex and large-scale project from start to finish. Responsible for the full project lifecycle: planning, execution, and delivery. Integrate supply chain, GMs of different sites; commercial groups, product development, and corporate finance to complete 23 different and complex roadmaps, consolidation, expansion, and real estate optimization. The combination of projects will deliver over $200M in synergies. Leads the sourcing, evaluation, and execution across USA and Latin America.

Assoc. Director of Operations

Zimmer Corporation Warsaw, IN 2012-2015

Responsible for managing the Tibias / Articular Surface manufacturing value Operations under the Orthopedic Division-Knee Business. Develops annual Budgets to balance corporate targets with business needs. Develops and grows organizations’ capabilities in Lean Manufacturing Six Sigma and business continuity. The operation includes 225 employees, 7 business segments, and 2 manufacturing plants with overall sales of $1.2B and COGS of $350M.

Implemented QCDSM in all manufacturing plants as our standard KPIs.

Reduced the cycle time by 35%. Reduced scrap levels by 35% in Vivacit E in Plant 19 Warsaw.

Reduced scrap by 20% in the machining operations for Std. Poly applying new programming

techniques. Implemented a double-stack concept in the Molding Dept. that generated a cost-saving of $1MM. Manage 54 molding Presses in a 3-shift operation.

Improved the Morale of the organization by promoting production associates' participation in quality teams and suggestion programs. Member of the Corporate CAPA committee.

Zimmer Corporation, Puerto Rico 2011-2012

Lead validation initiatives in the areas of CSV within Manufacturing.

Provided expertise in the implant division in the areas of CSV Manufacturing, Engineering, and Quality. Supervised a team of engineers that provided expertise in IQ/ OQ/PQ in the CSV area.

Vice President Global Sourcing

TECHNO PLASTICS INDUSTRIES CORP. Puerto Rico 2009 - 2011

Responsible for managing the business operation Supply Chain and the expansion of the operation. Responsible for Sales and Operation Planning. Evaluate forecast, production capacity, and Inventory Management. Apply forecasting model. Led consignment negotiations, licensing, and acquisitions. Responsible for developing the workforce to promote internal growth and business development. Expanded the business in the USA, Dominican Republic, and the Caribbean by 20 % and managed the commercialization of the company. The plant included 250 employees including 24 molding presses, two cleanroom class 100, and medical device assembly areas.

Consolidated the planning and production capacity in the medical business.

Managed the business growth in the assembly of medical devices and neurosciences.

Negotiated contracts with customers that represented $15MM in sales.

Consolidated freight forwarder companies to improve lead time and reduce cost.

Developed consignments agreements with Abbott Medical Optics (J&J) and Carefusion (Cardinal Health). Increase margin by 12% after implementation just in time and one lot flow in the injection molding plant. Leads the sourcing, evaluation, and execution across the USA and Latin America.

Senior Director Critical Care

EDWARDS LIFESCIENCES LLC, Geneva, Switzerland, Europe 2007 – 2009

Responsible for the Operations of the Hemofiltration business in Europe. Manage the logistics, supply chain, and contract negotiation in the OEM business in Europe with manufacturing plants in Italy, Germany, and Ireland. The operations represent $110 MM in OEM products which involve R&D, Marketing, Manufacturing, Sales, Supply Chain, Logistics, Quality, Inventory Management, and Technical Support. Responsible for the P&L for the Hemofiltration Division.

Implemented a combination of suppliers to effectively satisfy the demand of the business and manage the business sales managers in around 15 European countries.

Led the effort of registering 15 European countries applying a DCP to distribute Hemofiltration solutions.

Managed cost savings projects that produced $4MM in cost reductions.

Managed the registration process for DCP in Europe and Pharmaceutical Licenses in European countries.

Negotiated contracts with suppliers that represent $25MM in product devices.

General Manager

EDWARDS LIFESCIENCES AG, Irvine, CA, and the Dominican Republic

Managed $210M in sales in the Critical Care Division. The facility included molding, sensor assembly, fully automated monitoring system lines, and 1,590 employees.

Installed a culture of continuous improvement utilizing Lean Manufacturing and improved the output by 40 %.

Launched the new generation of Flo Trac (monitoring system) and sustained a 100% in service level.

Consolidated Production in Thailand and improved the capacity of Monitoring Systems in Japan by 50%.

Negotiated contracts with suppliers in the Dominican Republic and the USA for the monitoring business. Managed the Inbound and outbound operations. Negotiated contracts with FEDEX and UPS with a reduction of $2.5 million. Overall contracts of $35 million. Managed contracts with Ocean carriers such as Maersk and Hapag-Lloyd.

Site Director and General Manager, Nellcor and Puritan Bennett Respiratory Division, Tijuana, Mexico

TYCO INTERNATIONAL (Healthcare Division) Medtronic, San Diego, CA 2002 – 2006

Managed a $200M COGS global manufacturing facility serving Balloon Catheters, Guide Wires, Enteral Feeding bags, Urology catheters, Imaging, Syringes, Oxysensors, and respiratory equipment business units. The responsibilities included 3 complex manufacturing plants with 3,300 employees under the Maquiladora agreement in Tijuana, Mexico.

Achieved $4M in cost reductions by establishing lean manufacturing and six sigma projects.

Provided basic Lean Manufacturing training for over 3,000 employees

Improved the efficiency by 20 % for the catheters in the Urology market.

Provided strategic Manufacturing support to facilities in France, Italy, Ireland, and Mexico with a service level of 98%.

Managed contracts and biddings with GPO’s Consorta and Ascension for the Autosuture (Laparoscopic business for US Surgical-Covidien). These contracts added $75 million in sales. Established a complete program named Strategic Sourcing Initiatives to consolidate plastics, corrugated, and metals suppliers that represent $100 million in cost of production, after consolidating from 50 plastics suppliers to 11 suppliers and from 8 corrugated suppliers to 3 suppliers and strategically located metal suppliers in Europe, USA, and Central America with cost reductions of $13 million. Member of the committee that negotiated the consolidation of one main carrier for Tyco International reduced the overall spending from $950 million to $750 million per year. Leads the sourcing, evaluation, and execution of transactions across the USA and Latin America.

General Manager

Tyco International (Healthcare Division) -Medtronic, Ponce, Puerto Rico

Managed $220M in COGS for a complex 1,650 employees plant serving the surgical medical device market. Managed the Auto Suture and Suture business's domestic and international market supply chain.

Chairman of the Operational Excellence program that drives Lean Manufacturing and Six Sigma programs. Managed the worldwide Laparoscopic and Access business.

Reduced the Cost of Production by 20%.

Improved on-time shipments by 22%.

Established the Six Sigma concept and Certified 5 Black Belts.

Converted 60 % of the production floor to the cell manufacturing concept.

Reduced raw materials inventory from $ 52 million to $ 18 million (65%).

Led the effort to qualify for $1 million in incentives from the Puerto Rico Industrial Development Corporation.

Operations Director & General Manager

PALL PUERTO RICO, Fajardo, Puerto Rico 2001 – 2002

Established operational objectives, budget, marketing objectives, policies, and general administration. Coordinated marketing strategy with distributors. Improved incentives, tax strategy, and relations with the government. Established short and long-term plans to respond to market variations.

Increased profit margins from 15% to 34 % in the Biopharmaceutical group and overall pre-tax earnings of 44%.

Consolidated the profile and industrial filtration businesses.

Increased sales by 20 % for Puerto Rico operations.

Director of Manufacturing and Engineering Caribbean Operations

CORNING CABLE SYSTEMS, Puerto Rico 1997 – 2001

Aligned plant policies with the company and divisional policies and objectives in the areas of general administration, industrial expense, plant security, maintenance, material movement, public relations, and planning for short and long-term growth. Managed all automated product lines and design projects. Coordinated all product introductions and product transfers with corporate management and marketing managers.

Achieved 24% in net profit after taxes.

Increased manufacturing capacity to support sales growth of15.7%

Completed a $12M plant expansion to accommodate 48 molding machines.

Consolidated three separate building operations into one main operation.

Achieved $4M in cost reduction projects.

Achieved 98% in customer satisfaction.

Negotiated tax exemptions in Puerto Rico with the partnership of the Corporate Finance Team of Corning Corp.

Operations Manager

PALL BIOMEDICAL, INC., Fajardo, Puerto Rico 1993 – 1997

Managed all manufacturing areas of blood filtration sets and intravenous solutions filters for domestic and

international markets. Coordinated all production transfers with the Research and Development Director in Pall East Hills, New York. Prepared and monitored budgets for the manufacturing department. Participated in corporate decisions to relocate products in Europe and Latin American countries (Costa Rica, El Salvador, and Ireland).

Increased the manufacturing volume from 200K filters to 1.6 million filters per quarter (700%).

The reduced standard cost by 45% following the implementation of several cost-reduction projects.

Reduced the manufacturing overhead rate by 36%.

Consolidated 97% of the domestic market into Puerto Rico operations.

Expanded the international market for Pall Biomedical Operations in Puerto Rico with the addition of the Japanese Intravenous market.

Senior Manufacturing Project Engineer

ALLERGAN MEDICAL OPTICS, Santa Ana, California & Puerto Rico 1991 – 1993

Managed the development of new products with the Research & Development Department in Irvine, California. Responsible for designing and constructing the facility for a new Intra Ocular Lens product. Developed all capital projects and budgets for the year. Provided technical expertise in molding and mixing for the Polymer department. Responsible for the ultrasonic welding area using polypropylene material. Responsible for the silicone molding facility with 25 molding presses.

Built a complete manufacturing facility ahead of schedule resulting in additional revenues for the company.

Developed a new product for the Intraocular lens market.

Developed a new system for injection molding, design, construction, validation, and start-up.

Manufacturing and Engineer Supervisor

BAXTER HEALTHCARE CORPORATION-BENTLEY DIVISION, Añasco, Puerto Rico 1989 – 1991

Managed the manufacturing process of production lines. Maintained the production department with positive manufacturing variances to meet the production forecast. Responsible for work assignment and manpower planning, department loading, production training, hiring, performance appraisal, and engineering projects in Standard Products.

Established "Just in Time" production lines generating $ 1.2M in favorable labor variance.

Transferred new products and consolidated the cardiovascular business in Puerto Rico.

Engineer support 23 injection molding presses in a cleanroom environment.

EDUCATION

Doctorate in Nutrition-Clinical

Universidad Internacional Iberoamericana, Puerto Rico- Thesis in process

Master Business Administration-Finance and Investment

Inter American University, San Juan, Puerto Rico

Bachelor of Science Industrial Engineering

University of Puerto Rico, Mayagüez, Puerto Rico

OPERATING AND GENERAL MANAGEMENT QUALIFICATIONS

Multi-Site Operations Management Budgeting and Expense Control

Project Management Regulatory Management (FDA-CFR 820,210,211, EPA)

New Facility Start-Up Staff Development and Motivation

Policy and Procedure Development Price and Contract Negotiations/Business Development

Product Account Development Quality Systems Development, ISO 13485, ISO 9001

Good Manufacturing Practices (GMP) FAA

AS9100D, ARP4754, ARP4761 FEA

Training and Certifications

Six Sigma Black Belt Certified, PR Lean Manufacturing, Rio Grande, PR

Solidworks toolset, Melbourne, Fl Impact Presentation-Dale Carnegie, Boston, MA

Project Management-Microsoft Project Six Sigma Champion, North Haven, CT

Hemofiltration Systems, Geneva, Switzerland M-1 Artificial Intelligence, Mayagüez, Puerto Rico

FDA's Quality System Regulation, Washington DC Surgical Procedures and Sutures, Ponce, Puerto Rico

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