Engineering & Quality Executive | Medical Device Industry Leader | Management Representative
Experienced engineering leader with 25+ years in the medical device industry, specializing in Endovascular, Neurovascular, and Cardiovascular guidewires and catheters. Proven record of leading from the front, taking ownership of cross-functional initiatives, and delivering value to both internal and external customers. Broad expertise across R&D, Manufacturing, Quality, and Regulatory functions, with a reputation for solving complex problems and guiding teams through product lifecycle and regulatory challenges. Proven competitive mindset as a masters-level track cyclist, bringing discipline, resilience, and performance under pressure to excel in high-stakes, goal-driven environments.
Guidewire and catheter development for interventional procedures
Product and process validation (IQ, OQ, PQ)
FDA/ISO compliance, ISO 13485:2016 QMS
Risk Management (DFMEA, PFMEA), CAPA, SCAR
Cross-functional leadership, team development, and audit readiness
Product lifecycle management from R&D to commercialization
Manufacturing transfers, supplier quality, and inspection oversight
Six Sigma Belt Trained (2004)
ASQ Certified Quality Auditor (2012)
ISO 13485:2016 Lead Auditor (2022)
International Medical Industries — Pompano Beach, FL
Jun 2024 – Present
Led introduction and validation of new manufacturing equipment technologies.
Sustained validated state of key production processes through periodic review and updates.
Executed QMS software validation for new versions, ensuring regulatory compliance.
East End Medical I — Miramar, FL
Jan 2023 – Jun 2024
Lead all Quality activities for a startup manufacturing Steerable Balloon Catheter Systems.
Represent management in audits and ensure ISO/FDA compliance.
Launch new products (K240600), manage QMS performance, and serve as key liaison with leadership.
ZimVie — Palm Beach Gardens, FL
Sep 2021 – Jan 2023
Led and managed QA Product Development programs and cross-functional Qualitity initiatives.
Strengthened supplier relationships and ensured continuous compliance with ISO 13485.
Cerenovus (J&J) — Miramar, FL
Nov 2013 – Sep 2021
Managed Receiving Inspection & QC teams.
Represented Quality in product launches and supplier engagements.
Improved audit readiness and operational compliance.
Biomet 3i — Palm Beach Gardens, FL
May 2011 – Nov 2013
Owned Supplier Quality processes, including risk mitigation and audit compliance.
Implemented supplier CAPAs and aligned product documentation with FDA standards.
Motorola Solutions — Plantation, FL
May 2007 – Nov 2011
Led Government Public Safety projects, supplier qualification, and verification efforts.
Improved field reliability through design changes, customer support and crossfunctional collaboration.
Boston Scientific — Doral, FL
Nov 2002 – Nov 2007
Managed line transfer projects to Costa Rica with full process validation.
Authored technical documentation and ensured seamless production ramp-ups.
Crisp Medical — Fort Lauderdale, FL
Jan 2001 – Nov 2002
Directed early-stage product development projects.
Balanced regulatory and technical needs to accelerate product readiness.
Cordis (J&J) — Miami Lakes, FL
Nov 1996 – Jan 2001
Supported full guidewire manufacturing operations.
Led drug coating process transfer from NJ to FL.
Collaborated with R&D to bring new designs into production.
B.S. in Mechanical Engineering
University of Florida – Gainesville, FL (1995)