Mark Ross Email & Phone Number

Oceanside, CA, US

Irvine, California, US

Employee #2 at a Biotech / Med Device Company.Implement Quality Management System.Design and Implement Product Development Process.Customer interviews and customer requirements specifications.Supplier / Vendor Management.

For over 20 years, I have been helping Fortune 500 businesses refine strategy, launch products, implement LEAN 6 Sigma manufacturing systems, optimize inventory and improve employee engagement. Now I bring Fractional and Affordable services to small and medium businesses. Start Ups - Let me help you build a business around your product.Established.

Irvine, CA, US

• Responsible for Manufacturing multiple medical devices in multiple locations.
• Led the manufacturing organization to successful FDA PMA audit with zero findings.
• Partnered with R&D to resolve product / machine challenges.
• Ramped production for successful launch of two new products for the Detour therapy.
• Increased productivity by over 20% on the primary product in each facility.
• Created metrics for measuring productivity in individual value streams which allowed us to identify, understand and improve productivity and predictability.

San Diego, California, US

• Responsible for Supply Chain, Sourcing, Manufacturing, Quality, Regulatory, Continuous Improvement, Shipping/Receiving and Repairs in a highly regulated environment.
• Led supplier sourcing, development and contract negotiations for critical suppliers and PCBAs both domestic and overseas.
• Implemented APICS-based ROP, ROQ and MOQ into ERP system.
• Created supplier audit form (and metrics) and led supplier audits.
• Performed supplier risk analysis on current and potential suppliers / OEMs.
• Responsible for negotiating Supplier Master Agreements.

Minneapolis, MN, US

• Santa Ana Site Lead for Structural Heart and member of the Structural Heart Value Stream Operations Leadership Team. Direct responsibility for 240 employees.
• P&L responsibility for $30M operation, across 7 clean rooms, 240 employees.
• Maintained Best-In-Class employee engagement with scores above 80.
• Participated in Corporate Strategic Planning and collaborated with manufacturing in USA, Mexico and China.
• $500K positive to AOP plan in first two quarters through operational and yield improvements.o Led and coached cross-functional tiger teams and LEAN transformations to quickly solve yield, capacity and supply constraint.

Minneapolis, MN, US

• Responsible for management of 4 production lines (200+ employees) for Surgical and Transcatheter Heart Valves.
• New Product Introduction for two new products.
• Strong people leader who enjoys my team and wants to provide a great work environment.
• Increased Engagement score by 13 points to 85% in one year.
• Mentored LEAN leaders as they led line transformations and continuous improvement projects with the use of DMAIC processes, Kaizen events, DOEs, A3s, problem solving activities and Gemba walks.
• Introduced LEAN principles and productivity tools; such as, 1 piece flow, Pull vs Push, line balancing, First Time Quality, productivity metrics and visual management.

Abbott Park, Illinois, US

• Collaborated strategy across matrix organization for product launch / retirement, inventory balancing, cold chain, elimination of back orders, and expiry reduction for Class II and Class III medical devices in the.
• Led implementation of Supply Chain processes (Planning and Scheduling) for the Murrieta facility. Completed implementation 2 months early.
• Designed and implemented Rough Cut Capacity Planning process and tools in order to provide centralized capacity planning data/analysis to 7 shared services organizations.
• Coordinated strategy for product launch / retirement, inventory balancing, cold chain, elimination of back orders, and expiry reduction for Class II and Class III medical devices.
• Planned and facilitated Best Practices Workshop for Supply Chain Management teams in 7 business units across four countries.
• Responsible for development of custom scheduling database, consolidating schedules of multiple guidewire production lines to provide single schedule for upstream sub assembly area (Access, SQL, VB, Excel)

Abbott Park, Illinois, US

• Management of multiple production lines and up to 120 direct reports for Class II and Class III medical devices.
• P & L responsibility.
• Created micro-business-management teams for each production line in the Endovascular Operations division. Resulted in increased cohesion in goals and focus. Improved ability to achieve target inventory levels and Cost.
• Multiple LEAN implementations (5 projects / manufacturing lines) driving productivity improvements from 10 – 41% per project.
• Project management across multiple business units / countries.

Abbott Park, Illinois, US

• Lead a cross-functional team to drive culture change and decrease cost by $1.5MM annually.
• Coordinated cross functional efforts across 4 business units, in 6 facilities, in USA, Puerto Rico, Ireland and Costa Rica to develop a single process that was approved by consensus of 30 individuals.

Abbott Park, Illinois, US

Provide supervision for 50+ employees and team leads in the manufacture of medical devices.

• Responsible for completing a leveraged-buy-out acquisition of a small business.
• Managed all P&L responsibilities.
• Implemented new CRM software and financial software.
• Developed marketing campaigns
• Developed metrics to track productivity of employees.
• Created procedures to ensure consistent operations performance.

Fullerton, CA, US

Taught Marketing, Sales and Management courses in on-site and remote formats.

Atlanta, Georgia, US

Fremont, CA, US

Sunnyvale, CA, US

Redmond, Washington, US

Master Of Business Administration - Mba, Entrepreneurship/Entrepreneurial Studies

Ba, Bible & Youth Ministry