Provide high-impact regulatory compliance, operational efficiency, and executive risk assessment consulting to private equity firms and life sciences companies.
• Regulatory & Compliance Remediation: Architect and Program Manager for $8M+ ZimmerBiomet FDA 483 remediation program, closing 15+ workstreams spanning compliance, post market surveillance, product risk, manufacturing, sterilization, packaging, QMS, Water systems, environmental control systems and IT systems.
• Designed the program governance including workstream charters, meeting hierarchy, and workstream labor tracking and budgeting.
• Established CAPA-driven processes to address 483 observations, managed weekly status updates for 50+ observation owners, to include providing technical CAPA guidance and assistance.
• Responsible for FDA response reporting for 4+ years never missing a committed submission deadline, the first of which was 30,000+ pages and submitted on time within the 20-day deadline.
SmartSheet Tracking

• Responsible for ~$60M budget covering global operations, supply chain, manufacturing engineering and IT.
• Led initiatives that increased EBITDA by £17M and Cash Flow by £22M
• Optimized working capital by improving Days Sales Inventory (DSI) from 127 to 77 days, freeing £239K in cash flow.
• Improved forecast accuracy (MAPE) from 18% to 15%, reducing bias from 13% to 6%.
• Collaborated on an FDA 483 response within 15 days, meeting the deadline for the first time at Corin.
• Implemented Lean Six Sigma, delivering $1.5M in first-year savings.
• Optimized supply chain procurement, reducing inventory costs by $6M+ and consolidating global suppliers for an additional $3M in savings.
• Spearheaded MES implementation, improving real-time operations visibility, reducing lead times, and minimizing scrap issues.
• Initiated a global inventory reduction program to include an obsolescence project and a trunk-stock reclamation program. Recovered £1M in underutilized field inventory

• Worked with KKR consultants on the business launch and expansion strategy under Biomet's PE ownership.
• Designed the consulting strategy for operations excellence across orthopedic Service Lines. Enlisted the kaizen approach for each process in the service lines, to include creating efficient flow in the ORs and improving OR protocols that reduced anesthesia time for patients and improved pain management protocols that enabled patients to ambulate as quickly as 1 hour post op, which greatly reduced recovery times for hip and knee implants.
• Designed and executed growth & profitability initiatives, securing $1.2M in first-year revenue.
• Reduced patient length-of-stay from 7 days to 2.5 days, optimizing OR efficiency by 30-50%. LinkedIn

• Led PE-backed Lean transformation, delivering $40M in bottom line cost savings across 3 years and EBITDA growth post-acquisition.
• Initiated end-of-line solutions for clean/passivate processes breaking down the bottleneck monument process and reducing lead times by 3-5 days in value streams.
• Implemented Con-WIP methodology and reduced WIP in high volume value streams by 50%+.
• Created a global lean training program and optimized two new manufacturing plants in China.
• Facilitated operational and transactional Kaizen Events both domestically and internationally across all departments driving multi-million-dollar savings.

• Led turnaround of $60M revenue business unit slated for closure with no additional resources, transforming a traditional job shop into a lean cellular operation within one year.
• Implemented cross-functional matrix reorganization with shared accountability and co-located teams. Enabled empowered teams with autonomous ownership of business unit improvement plans. Increased morale and operational emciency.
• Designed and executed a structured Business Unit - Value Stream - Kaizen strategy (1-week event, 3- week execution & validation cycle), achieving turnaround in just over one year. Transactional support groups were also included in business unit structures: procurement, finance, regulatory, sales & marketing.
• Increased $2.5M in Value of Production (VOP) at a $60M facility without adding headcount or machines, improving EBITDA.
• Reduced scrap/rework by >30%, improved First Pass Yield from 65% to 98%, and cut lead time from ~22 days to 1 day in highest volume product cell.

• Certified Lean Six Sigma Master Black Belt, spearheaded global QMS, CAPA, and continuous improvement programs.
• Architect of Transactional Kaizen process: facilitated successful kaizen events across HR, Quality and Regulatory, Engineering and R&D, Sales & Marketing: recorded in millions of finance department validated cost savings.
• Implemented Hoshin Kanri across Quality & Regulatory, reducing transaction bottlenecks.
• Patent Holder: Developed ultrasonic defect-reduction techniques for ophthalmic lenses, reducing the number one and two product defects, chips and tears, by 90%+. These defects occurred for all products, impact was multi-million savings and improved reputation.