Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Additional Information
Final Recommendations
Moving Forward
2004 Medical Design Excellence - Silver Award for Design & Development of HealOzone
Timeline
Generic

Paul J. Garcia

Los Angeles

Summary

Operations leader prepared for senior roles in driving efficiency and growth. Proven track record in optimizing processes, enhancing productivity, and leading cross-functional teams to success. Strong skills in strategic planning, project management, and resource allocation. Known for adaptability, fostering collaboration, and delivering measurable results in dynamic environments.

Overview

29
29
years of professional experience
1
1
Certification

Work History

Sr. Director of Operations

Skye Biologics / Human Regenerative Technologies
11.2022 - 12.2024
  • Led the transformation process of converting donated placental tissue into advanced skin substitute wound care products
  • Spearheaded process development for new products and sustained engineering efforts
  • Standardized operations, reducing reprocessing and enhancing efficiency
  • Doubled throughput, resulting in a100% increase in top-line revenue within the first 12 months
  • Developed predictive planning tools for accurate demand forecasting, ensuring timely availability of supplies and resources
  • Led change management efforts to successfully implement new technologies and systems across the organization.
  • Developed and executed operational plans to achieve organizational goals.
  • Mentored team members, fostering a culture of professional growth and development.
  • Optimized supply chain performance by establishing strong vendor relationships and improving inventory management systems.

Sr. Operations Manager

Abbott
11.2015 - 11.2022
  • Led production and manufacturing engineering personnel for ablation and imaging catheter manufacturing across multiple production lines and multiple shifts
  • Managed over 300 personnel effectively by installing operational infrastructure rooted in lean manufacturing concepts
  • Oversaw workforce management planning, volume predictions and capacity planning.
  • Directed strategic site planning, resource allocation, and project loading
  • Built strong relationships with key stakeholders through consistent engagement, collaboration, and transparent communication practices.
  • Administered an annual budget of $1.9M in operating expenses and $150K in capital expenditures
  • Deployed Root Cause Analysis standard work, reducing line downtime and optimizing processes
  • Implemented Kanban systems, reducing work-in-process inventory and enhancing workflow efficiency
  • Developed and delivered internal compliance training, including Line Clearance Procedures, GDP, and Gowning
  • Established a safety team, conducting regular safety walks and reducing OSHA recordable rates from12.5 in2015 to5 in2016
  • Improved employee morale through skip-level meetings, fostering open communication and engagement
  • Cultivated talent by creating development plans for supervisors and engineers
  • Ensured compliance with ISO13485 standards and FDA regulations

Manufacturing Manager II

B. Braun Medical
08.2013 - 11.2015
  • Managed primary filling operations for high-volume saline and nutrition IV solutions, producing approximately100 million units annually
  • Led a team of over270 personnel through 4 manufacturing supervisors
  • Facilitated daily production and MRB meetings to drive quality and productivity improvements
  • Conducted root cause analysis investigations to identify areas for improvement in manufacturing processes, leading to increased efficiency and fewer defects.
  • Conducted risk assessments for technology obsolescence, coordinating with technical services for proactive solutions
  • Championed cost savings and continuous improvement initiatives, enhancing operational efficiency
  • Implemented compliance audits to ensure adherence to company policies and regulatory standards
  • Drove effective problem-solving through employee engagement and Lean principles
  • Achieved budgetary goals, managing operational expenses and optimizing resource utilization
  • Developed scalable operational models to support increased production output
  • Introduced an employee recognition program, boosting morale and performance

Associate Operations Manager

Covidien Neurovascular
05.2012 - 05.2013
  • Managed day-to-day operations of5 production lines in neurovascular catheter assembly within a high-mix, low-volume, high-margin manufacturing environment
  • Supervised a focus factory staff of approximately100 employees across multiple shifts
  • Streamlined team structure to enhance clarity and operational efficiency
  • Developed inventory management systems to optimize stock levels and reduce waste
  • Achieved monthly build plans by providing clear direction and aligning resources
  • Optimized production processes and line layouts, improving yields to over90%
  • Maintained compliance within a cGMP environment adhering to ISO13485 and FDA regulations

Production Manager

Interface Catheter Solutions
11.2009 - 05.2012
  • Managed operations for disposable balloon and extrusion production with a team of approximately30 staff
  • Established a self-sufficient operation by implementing robust personnel infrastructure
  • Enhanced manufacturing environment through visual management and JIT material replenishment
  • Reduced cleanroom particulate levels by instituting stringent cleaning procedures
  • Increased capacity and minimized overtime through strategic scheduling
  • Decreased machine change-over time from8 hours to1 hour, significantly boosting efficiency

Manufacturing Manager

SenoRx Inc.
07.2006 - 11.2009
  • Managed assembly operations for disposable breast biopsy probes with a team of approximately50 employees
  • Built operational infrastructure including supervisors, line leads, technicians, and training coordinators
  • Improved throughput by optimizing floor layouts and doubling production capacity
  • Fostered organizational communication through regular forums and meetings
  • Developed a showcase manufacturing floor, exemplifying best practices in operations
  • Operated within a cGMP environment under ISO13485 and FDA regulations

Assembly Manager

Pro-Dex Inc.
12.1995 - 07.2006
  • Managed short-run manufacturing operations for OEM medical and dental devices with a team of approximately25 staff
  • Expanded capacity by establishing a second shift, enhancing production capabilities
  • Improved supply chain efficiency through JIT systems with key suppliers
  • Optimized planning parameters, resulting in a15% improvement in on-time delivery
  • Led the successful transfer of assembly lines to facilities in Oregon and Mexico
  • Ensured compliance within ISO13485 standards and FDA regulations

Education

Master of Business Administration -

University of Redlands
01.2006

Bachelor of Science - Business Administration

DeVry University
01.2003

Skills

  • Lean Manufacturing & Operations
  • Process Optimization & Standardization
  • Strategic Planning & Execution
  • FDA & cGMP Compliance
  • Cross-Functional Team Leadership
  • Workforce planning
  • Budgeting & Financial Management
  • Root Cause Analysis
  • Supply Chain & Inventory Management
  • Talent Development & Mentorship
  • Continuous Improvement Initiatives

Certification

  • Lean Six Sigma Green Belt
  • Dale Carnegie Leadership Training
  • FDA Regulatory Compliance Workshops

Affiliations

  • Member, American Production and Inventory Control Society (APICS)
  • Member, Association for Operations Management

Additional Information

  • Languages: Proficient in [include any additional languages if applicable].
  • Volunteer Work: [Include any relevant volunteer work or community involvement].
  • Publications/Patents: [List any publications or patents if applicable].

Final Recommendations

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Moving Forward

  • Your career showcases a trajectory of increased responsibility, leadership, and successful outcomes in complex operational environments. Emphasizing these accomplishments positions you as a valuable asset to potential employers.
  • If there are specific roles or industries you're targeting, let's delve deeper into tailoring your CV to those opportunities. Additionally, we can work on crafting a compelling cover letter to accompany your applications.
  • Feel free to share any additional information or preferences you have, and together we'll ensure your CV not only looks more professional but also truly represents the exceptional leader you are.
  • I am seeking a Director of Operations or Vice President of Manufacturing role
  • Great choice! Aiming for roles like Director of Operations or Vice President of Manufacturing aligns perfectly with your extensive experience and leadership skills. Here are a few tailored enhancements to your CV that will emphasize your qualifications for these executive positions:

2004 Medical Design Excellence - Silver Award for Design & Development of HealOzone

Now a KaVo product produced in Germany the HealOzone was created to treat dental caries without risk of further damaging the affected tooth.  This one-in-a-lifetime project started with a cocktail napkin diagram of the ozone generator.  I was given the opportunity to act as the project manager and took it from the napkin through testing and development; through manufacturability into production and finally transferred the production line to another facility.  A successful finish to the project without a doubt.  This project exposed me to every facet of the business and ultimately provided the knowledge and experience I would use in my subsequent roles.  

Timeline

Sr. Director of Operations

Skye Biologics / Human Regenerative Technologies
11.2022 - 12.2024

Sr. Operations Manager

Abbott
11.2015 - 11.2022

Manufacturing Manager II

B. Braun Medical
08.2013 - 11.2015

Associate Operations Manager

Covidien Neurovascular
05.2012 - 05.2013

Production Manager

Interface Catheter Solutions
11.2009 - 05.2012

Manufacturing Manager

SenoRx Inc.
07.2006 - 11.2009

Assembly Manager

Pro-Dex Inc.
12.1995 - 07.2006

Bachelor of Science - Business Administration

DeVry University
  • Lean Six Sigma Green Belt
  • Dale Carnegie Leadership Training
  • FDA Regulatory Compliance Workshops

Master of Business Administration -

University of Redlands
Paul J. Garcia