Work History

Alphatec Spine 2015 to 2017

Sr. Director Compliance

Directed compliance organization for established orthopedic medical device manufacturer realizing Class I/Class II/Class III Spinal Fixation/Fusion, Spacer, and Deformity Correction medical device instrument, implant, and biologic products (Cages, Screws, Rods, Plates, Tissues, Cements, Probes, Drills, Taps, Drivers, Torque Wrenches)

 

Philips IGT (Volcano Corporation) 2015 to 2015

Director Complaint Handling & Safety Reporting

Directed complaint handling organization with twenty-eight direct and indirect reports (Consultants, Sr. Manager, Supervisor, Field Investigation Engineers, Coordinators, Product Performance Specialists) performing complaint analysis, trending, and adverse event/incident reporting (MDR and MDV) for all coronary as well as peripheral disposable Intra Vascular Ultra Sound (IVUS) catheter, Functional Management (FM) guide wire, Atherectomy catheter, Vena Cava filter, Chronic Total Occlusion (CTO) catheter and durable Imaging and Pull Back system devices

 

OncoSec Medical 2012 to 2014

Executive Director Quality Assurance & Regulatory Compliance

Developed, implemented, and managed quality assurance function for a start-up bio-technology firm realizing a Class II/Class III Electroporation medical device (pulse generator, applicator handle, applicator tip)

 

CeloNova BioSciences (Nexeon MedSystems) 2006 to 2011

Sr. Director Quality & Regulatory

Developed, implemented, and managed quality organization and infrastructure for start-up and established medical device organizations realizing Class II and Class III medical device products (Embolic Protection, Dilatation Catheter, Self Expanding Stent, Balloon Expanding Stent, Multi-Needle Injection, Embolic Microspheres)

 

Abbott Laboratories (Guidant Corporation) 1989 to 2006

Quality Engineering Manager (2005 to 2006)

Managed quality engineering organization with forty-seven direct and indirect reports consisting of Group Leaders, Quality Engineers, Reliability Engineers, Technicians, QC Supervisor, and QC Auditors for Class II and Class III medical device products (Embolic Protection, Dilatation Catheter, Self Expanding Stent, Balloon Expanding Stent, Drug Eluting Stent)

Quality Assurance Manager (2004 to 2005)

Managed complaint handling organization with twenty-one direct and indirect reports (Group Leader, Lab Supervisor, Quality Engineers, Technicians, Product Performance Analysts) for Class II and Class III medical device products performing complaint analysis, trending, and adverse event reporting (MDR and MDV) for all Coronary Stent, Dilatation Catheter, Guide Wire, Guiding Catheter, Atherectomy, Congestive Heart Failure, Carotid Stent, Embolic Protection devices

Quality Engineering Manager (1999 to 2004)

Managed quality engineering organization with sixty-four direct and indirect reports consisting of Group Leaders, Quality Engineers, Technicians, QC Supervisors, and QC Auditors for Class II and Class III medical device products (Guide Wire, Guiding Catheter, Atherectomy, Accessory, Congestive Heart Failure)

Project Leader/Senior R&D Engineer (1995 to 1999)

Managed cross functional teams for new product development with representatives from Marketing, Regulatory Affairs, Non-clinical Research, Clinical Research, Manufacturing Engineering, and Quality Engineering for Class II and Class III medical device products

Document Control Section Leader (1993 to 1995)

Supervised document control organization for Class II and Class III medical device products with fourteen direct reports in Records Retention, Document Processing, CAD Drafting, and Product Label Creation

Manufacturing Engineer (1989 to 1993)

Investigated and resolved manufacturing problems resulting in low production yields and poor quality for Class II and Class III medical device products