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Medical Device Plant Manager

Location:
Sacramento, CA
Posted:
January 21, 2020

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Resume:

Michael R. Bula

Sacramento, California ***** / adbdec@r.postjobfree.com / www.linkedin.com/in/mikebula / 916-***-****

DIRECTOR/VP OF OPERATIONS

“Exceeding Bottom-Line Profitability through Lean Cost Reduction & Operational Improvements” Leadership Profile

Influential hands-on Operations leader with prior Director and Vice President of Operations / Executive Leadership experience focused on driving operational excellence to achieve ever improving results in effort to consistently shatter budgeted goals and targets. Proficient in defining best-of-class standards and methodologies while winning support of management, staff, and clients through active listening and fostering organizational enhancements and initiatives. Expertise in leading company start-ups, rebuilding and revamping mature businesses and integrating newly acquired acquisitions within a professional corporate environment where growth and profitability are essential to long-term sustainability. Proficient at driving bottom line success both domestically and internationally through management accountability while coaching any required mentoring & leadership skills through application of best demonstrated practices, process improvement and utilizing proper lean techniques in pursuit of improving value. Core Competencies

Developer of High Performing Teams P&L Management Accountability & Oversight DuPont Safety Training

ROI, COG’s, Gross Margin Analysis Strategic Planning & Implementation ISO 9000 Implementation

Environmental Health & Safety ERP, MRP, DMS, LMS, QRS & Oracle Systems Supply Chain Management

FDA & DEA Regulatory Compliance Quality Assurance Management Experience cGMP Certification

Coaching and Counseling Training Six Sigma Lean Manufacturing Training Succession Planning

Homeland Security Clearance Multiple Site Responsibility Professional Experience

Climb Society, Rehabilitation – Sacramento, CA 2018 – Present Climb Society offers quality performance equipment that caters to all levels ranging from rehabilitation clients to elite athletes. Primary goal is to implement a highly effective tool for strength training, endurance, toning, agility and overall health to the entire fitness community. This unique Start-Up business is new to the US and has exclusive national distribution rights. Vice President of Operations

Reporting to the CEO and responsible for establishing organizational operating systems, efficient supply chain systems, Lean distribution processes and driving product recognition throughout rehabilitation and therapy clinics nationwide.

Established overseas packaging and distribution operations and executing standard work procedures for US operations.

Managing warehousing and supply chain efforts while building inventory tracking and ID traceability systems utilizing Zoho integrated software. Currently focused on refining and creating a structured labor scheme for high volume variations. STERIS Corporation, Surgical Solutions – Point Richmond, CA 2017 – 2018 STERIS is a leading provider of infection prevention and procedural surgical products and services, focused primarily on healthcare, pharmaceutical, research and medical device Customers. Director of Operations

Reporting directly to the Division Vice President in the Ohio corporate office and responsible for the manufacturing and overall site leadership of operating room integration equipment while ensuring compliance with U.S. and foreign regulatory requirements. Successfully led the incorporation of a newly acquired California based business with 50 employees into the Steris network while redesigning and rebuilding the manufacturing facility and transitioning the business within the Steris culture.

Led facility expansion, transition of east coast legacy product and manufacturing of all ORI production equipment through Point Richmond, CA while improving processes and product quality by training employees in Lean concepts and approaches.

Sponsored numerous Kaizen initiatives utilizing lean methodologies to improve facility growth, process flow and improve efficiency of the production environment.

MICHAEL R. BULA RESUME (Professional Experience continued) PAGE 2 Zimmer Biomet, Surgical Division – El Dorado Hills, CA 2014 – 2017 Zimmer Biomet is the world’s leading innovator in musculoskeletal healthcare and offer a complete portfolio of products for joint reconstruction, bone and skeletal repair, sports medicine, spine, and dental reconstruction. Director of Operations

Responsible for the manufacturing facility in northern California and reporting directly to the Divisional President in Ohio, successfully led 100 employees in the manufacturing of surgical blades used primarily in orthopedic knee replacements. Working closely with quality, assuring all regulatory and quality standards are effective and audit ready. Responsible for driving world class safety, engineering, logistics, supply chain, distribution, maintenance and continued growth.

Instrumental in driving process improvements to completion, redefining and implementing effective organizational structure while maximizing equipment capabilities, expanding operations and improving gross margin growth. Sterigenics International, Inc. – Oak Brook, IL 1997 – 2013 Comprehensive Sterilization specialists with an emphasis on medical devices and on eliminating threats to humanity. With more than 90 years of expertise across Gamma, EO, E-beam and X-ray sterilization, operations span 47 facilities in 13 countries. Regional Vice President, Operations, North America – West, 2005 – 2013

Owned accountability for managing more than 300 employees throughout the Western Region in 10 processing facilities, while ensuring the integrity and delivery of more than $85MM in annual contract sterilization services of medical devices. Built strategic partnerships with many global medical device leaders while consistently improving performance through quarterly S&OP business reviews and by reducing damage claims in the region by more than $400K in one year.

Maintained leadership oversight of facility upgrades of up to $10MM in capital expense per location, while driving growth and expansion of a medical device processing up to $20MM in annual revenue increasing gross margin by more than 25%.

Instrumental in leading year-over-year reduction in regional recordable and lost time injury rates to < 1.0/mhw, while maintaining “zero recordable injuries” in the Hayward, CA facility for 16 consecutive years during 24/7 plant operations.

Ensured structural alignment, and throughput expansion of two facilities in Mexico, significantly improved quality performance, driving a customer satisfaction turnaround, 10% reduction in injuries and 20% improvement in gross margin.

Drove enhancements to the supply chain network in Mexico, reducing inventory and material costs by more than 4% while negotiating annual international union contract and labor costs. General Manager – Hayward, CA, 1997 - 2005

Served as a Primary Report to the Vice President of Operations, responsible for the start-up and development and year- over-year success of the Hayward, CA Gamma Radiation Operations Center. Ensured outstanding quality levels in all departments, and the highest gross profit margins in the network, while maintaining a flawless Safety Record of zero recordable injuries for 10 consecutive years, resulting in my promotion to Regional Vice President of Operations.

Instrumental in ensuring customer and regulatory audits while facilitating more than 1,000 hours of TQM team meetings and leading all Nuclear Regulatory Commission annual inspections.

Managed and maintained oversight of the successful implementation of GMP’s and 21 CFR’s, guiding the facility through ISO 9002 certification and the initial FDA inspection, consequently participating in ten years of subsequent annual FDA inspections all void of any 483 issuances.

Ensured integrity of all onboarding of new and start-up customers requiring specialized assistance with validation protocols, while consistently meeting all FDA and DEA requirements and regulations. Other Relevant Experience

SONOCO Products Company – Hayward, CA

Plant Manager

Sonoco is a global provider of a variety of consumer packaging, industrial products, protective packaging, and displays and packaging supply chain services. Net sales of $4.8 billion and 20,000 employees in more than 300 operations in 33 countries.

Recruited through Cal Poly as a graduating Senior and accepting the position of “Management Trainee” I began my career at Sonoco as the Production Scheduler and earned my way by promotion into increasing roles of responsibility including: Logistics Supervisor, Technical Product Specialist and Plant Superintendent before being promoted to Plant Manager. Education

Bachelor of Science, Industrial Technology

Concentration: Industrial Management

California Polytechnic State University, San Luis Obispo, CA



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