Dallas-Fort Worth Metroplex
Expanded leadership scope to include full product quality ownership for ArcticSun™ Targeted Temperature Management system, spanning design, software, cybersecurity, and post-market performance. Delivered global software remediation and associated applicable regulatory submissions, while driving design assurance across capital equipment and disposables. Continued to lead post-market quality for all UCC products and partnered cross-functionally to resolve customer issues.
Directed an 80+ person quality organization with a $7.4M budget, spanning complaint handling, CAPA, supplier quality, post-market surveillance, documentation & training, and IQC. Delivered a 40% reduction in complaint cycle time across two consecutive years, improved on-time US MDR reporting to >99.65%, while reducing headcount by 15%. Led successful audits securing ISO 13485 MDSAP and EU MDR certificates. Orchestrated enterprise-wide QMS harmonization. Built a high-performing, diverse team, placing 55% of high-potential talent into new roles.
Neuromodulation was an approximately $1B division focused on active implantable devices (Class III) for spinal cord and deep brain stimulation to manage chronic pain. Led Quality Engineering functions of ~70 employees, including Design Transfer, Operations Quality, Supplier Quality, CAPA, and Microbiology/Sterilization.
Led a 175-person Quality Engineering team across six locations supporting three product divisions, including active implantable devices for pain management and cardiac rhythm products. Restructured teams at two sites to align with the global network and improved efficiency by reducing inspection headcount. Successfully led simultaneous FDA (unplanned) and ANVISA (planned) inspections with zero observations.
Headed Manufacturing Quality for two sites (~50 employees), integrating an acquired facility’s products and QMS into the St Jude global network. Oversaw FDA inspection with no 483s. Coordinated global teams to address two field product issues and ensure effective field corrections.
Led team of 40, including 2 managers. Directly responsible for six production and three development lines, Calibration & Metrology, US distribution and in-house sterilization. Represented business unit in corporate Product Development Process redesign initiative, strategically ensuring process redesign represented active implantable deliverables. Key team member that remediated the Engineering Change approval process via CAPA root cause analysis to rapidly reintroduce product which was voluntary held from US market due to submission process concerns. Managed Supplier Quality Assurance for semiconductor component supply chain (spend > $15MM / year).
Managed a 15-member Manufacturing Engineering team across three shifts, driving product and equipment projects that improved output, cost, and quality. Interim 1st Shift Production Supervisor (60 operators) while retaining Engineering responsibilities. Led FDA warning letter response; updated specifications and guided company-wide remediation within six months. Earned President’s Award for leadership of cross-functional team that saved ~$1.2M by increasing material utilization by > 70%. Implemented Lean Manufacturing improvements which increased line productivity by 33% in 6 months.