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Curriculum Vitae                                                                                                                                                 

Ellen M. Golds                                                                                                                                                                                                                    

914.629.3253

egolds@verizon.net

                                                                                

U.S. Patents

8,764,815 Intraluminal Stent

8,118,858 Intraluminal Stent

8,048,138 Medical Device Retaining Sheath and Medical Device Delivery System

7,867,267 Stent Delivery System With Nested Stabilizer and Method of Loading Using Same

7,186,263 Mesh Graft and Stent for Increased Flexibility

6,881,221 Tubular Structure/Stent/Stent Securement Member

6,730,117 Intraluminal Stent

6,673,103 Mesh and Stent for Increased Flexibility

6,607,551 Stent Delivery System with Nested Stabilizer

6,533,806 Balloon Yielded Delivery System and Endovascular Graft Design for Easy Deployment

6,312,458 Tubular Structure/Stent/Stent Securement Member

6,001,125 PTFE Vascular Prosthesis and Method of Manufacture

5,976,161 Tissue Everting Apparatus and Method

5,383,905 Suture Loop Locking Device

5,356,417 Absorbable Sternum Closure Buckle

5,356,412 Sternum Buckle with Rotational Engagement and Method of Closure

 

Publications

“Sorbent Augmented Dialysis: Minor Addition or Major Advance in Therapy?” James F. Winchester, Claudio Ronco, James A. Brady, Ellen Golds, Jonathan Clemmer, Larry D Cowgill, Thomas E. Muller, Nathan Levin. Blood Purification 19:255-259; 2001.

 

“First Clinical Experience with an Adjunctive Hemoperfusion Device Designed Specifically to Remove b2-Microglobulin in Hemodialysis” Claudio Ronco, Alessandra Brendolan, James F. Winchester, Ellen Golds, Jonathan Clemmer, Hans Dietrich Polaschegg, Thomas E. Muller, Giuseppe La Greca  & Nathan Levin. Blood Purification 19:260-263; 2001

 

Technical Expertise

 

Product development:

  • Endovascular venous stents

  • Endovascular arterial stents, covered and uncovered

  • Stent delivery systems

  • Vena cava filters and delivery systems

  • Percutaneous pulmonary (heart) valve and delivery system

  • Abdominal aortic aneurysm covered stents and delivery systems

  • Ventricle-to-coronary artery bypass implant and delivery system

  • Neonatal and adult central venous catheters

  • Neonatal feeding tubes

  • Dialysis access catheters

  • Femoral hole closure devices

  • Fecal and urinary continence implantable devices

  • Sutures and needles, braided and monofilament, permanent and absorbable

  • Absorbable wound closure textiles and devices

  • Endoscopes, flexible and rigid, optical and digital

  • Ostomy devices

  • Minimally invasive surgical devices

  • “Smart diaphragm”, with (electrical) data collection systems for use with silicone rubber diaphragm

  • Disposable patient care devices, including blood warming bags, chest drainage units, hot and cold pads

  • Dental models

  • Blood filters and dialysis

  • Penile prostheses

 

Manufacturing processes and validation:

  • Catheter assembly processes

  • Stent loading (onto delivery systems)

  • Laser cut steel and Nitinol tube manufacture for stents and cardiac structures

  • Laser welded Nitinol stent manufacture

  • PTFE extrusion and expansion

  • Bench test design and testing of specialized vascular implant and delivery system

  • Balloon forming processes

  • Thermoplastic extrusion, including for catheter manufacture

  • Thermoplastic and thermoset injection molding

  • Ultrasonic welding of thermoplastics

  • Silicone rubber liquid injection molding, transfer molding, dip molding and assembly

  • Polyurethane dip molding

  • Prototyping of medical devices and their assembly processes

  • Textile braiding, weaving and knitting, absorbable and non-absorbable

  • Metals machining processes, including electron discharge machining

  • Collagen processing

  • Pharmaceutical packaging

 

Professional Experience

 

Golds Associates, LLC, Hastings on Hudson, NY (2012-Present)

Founder and Principal

     

Founded company to assist clients with medical device product development in the areas of vascular and cardiovascular implants and delivery devices, as well as minimally invasive medical devices and endoscopy.  

  • Currently engaged as project manager for multi-national pharmaceutical company. Managed $17 Million project to relocate stability labs.

  • Managed project team of 14 consultants and approximately 30 client investigators to complete 100 deviation investigations per week. Prepare weekly and monthly metrics from Trackwise modules, identify and track trends to help client plan solutions, manage quality assurance process improvement projects, lead daily meetings and give process training. Lead and coordinated data presentation for monthly site quality council meetings. Prepare related information for FDA and other audits.

 

Validant, San Francisco, CA (2011-2012)

Senior Manager

 

Quality and regulatory compliance consultancy supporting leading life sciences companies’ remediation efforts with strategic resources.  As Senior Manager, was responsible for clients in NY, NJ and CT area; increased the company’s contacts by more than 400 people at more than 80 companies. 

 

 

Golds Associates, LLC, Hastings on Hudson, NY (2008-2011)

Founder and Principal

     

Founded company to assist clients with medical device product development in the areas of vascular and cardiovascular implants and delivery devices, as well as minimally invasive medical devices and endoscopy.  

  • Assisted large orthopedic medical device manufacturer with multi-functional FDA warning letter response remediation effort as project manager reporting to project leads. Prepared schedules, led team meetings, followed up on action items, created metrics and reports. Efforts focused on critical process parameters, process validation, MDR, gauge design and calibration, purchasing and CAPA. Prepared slides for and attended weekly executive management review of remediation effort.

  • Supported back room for remediation team during 21-day FDA audit, kept CAPA document log, ensured prompt delivery of documents, supported general document tracking, followed up with team members for completion of outstanding audit tasks, facilitated communication between back rooms.

  • Supported CAPA team, assisted CAPA owners with creation of schedules, team meeting minutes and presentations for projects in New Jersey, France and Ireland. Created metrics and reporting formats, followed up with CAPA owners to progress CAPAs, assisted management and director with CAPA group strategy, created weekly executive and monthly divisional CAPA review metrics and presentations. Assisted in project management of corporate CAPA activities, CAPA process improvement projects, budgets and presentations.

 

 

AlvaMed, LLC, Waltham, MA (2004-2008)

Vice President, Product Development & Project Management

 

Consult on product design/development and assist with project management of medical devices, focusing on vascular and cardiovascular implants and delivery systems.

  • Endovascular venous stents

  • Stent delivery systems

  • Vena cava filters and delivery systems

  • Percutaneous pulmonary valve and delivery system

  •  “Smart diaphragm”, with (electrical) data collection systems for use with silicone rubber diaphragm

  • Neonatal and adult central venous catheters

  • Neonatal feeding tubes

  • Dialysis access catheters

  • Femoral hole closure devices

  • Fecal and urinary continence implantable devices

  • Ostomy devices

  • Minimally invasive surgical devices of many types

 

 

Golds Associates, LLC, Hastings on Hudson, NY (2001-2004)

Founder and Principal

     

Founded company to assist clients with medical device product development in the areas of vascular and cardiovascular implants and delivery devices, as well as minimally invasive medical devices and endoscopy.   

  • Ventricle-to-coronary artery bypass implant and delivery system

  • Balloon forming processes

  • Endoscopes, flexible and rigid, optical and digital

  • Pharmaceutical packaging

 

 

Renaltech International, LLC, New York, NY (2000)

Director, Product Development

 

  • Built polymer and device development departments 

  • Managed development and automation of absorbent copolymer bead synthesis process

  • Blood filters and dialysis

  • Thermoplastic injection molding

  • Ultrasonic welding of thermoplastics

 

 

Boston Scientific Corporation, Wayne, NJ (1997-2000)

Manager, Endovascular Peripheral R&D, Meditech Division

 

  • Endovascular arterial stents, covered and uncovered

  • Stent delivery systems

  • Catheter assembly processes, including stent loading

  • Endovascular iliac covered stent products technical support and development

  • Abdominal Aortic Aneurysm (AAA) leg stent products continuing engineering support

  • Product design and development of peripheral endovascular superficial femoral artery (SFA) covered stents, including development of Nitinol wire bare stent, polymer coverings and delivery system components

  • Invented or co-invented stent geometries, stent coverings, methods of covering stents to increase flexibility during delivery, and delivery system designs

  • Stent covering design work, focused on minimizing intimal ingrowth, while maximizing radial expansion force, column strength and flexibility for delivery

  • Led team to develop proprietary processes to extrude and expand PTFE for making ultra-thin tubular ePTFE structures as stent coverings, including design and production of specialty extruders and adaptation of company’s expansion process 

  • Practiced renal artery catheterization on in vitro and porcine in vivo models, attended classes in endovascular medicine, observed open vascular procedures such as carotid endarterectomy and cardiac bypass operations, and attended morning rounds.  Observed endovascular open and interventional procedures such as stenting, Mollring cutting in the SFA and leg artery bypass at various institutions

  • Medical device assembly processes

  • Thermoplastic injection molding

  • Textile weaving and knitting non-absorbable

  • Metals machining processes, including electron discharge machining

  • Laser cut steel and Nitinol tube manufacture for stents and cardiac structures

  • Laser welded Nitinol stent manufacture

  • Bench test design and testing, including of specialized vascular implant and delivery systems

 

 

 

Datascope Corporation, Montvale, NJ (1996-1997)

Manager, Product Development, Collagen Products Division

 

  • Femoral hole closure devices/catheters

  • Designed, built and tested prototypes, in vitro and in vivo, of improved mechanical and bio-active collagen femoral hole closure product (Vasoseal®) 

  • Developed blood in vitro and ovine in vivo models for coagulation 

  • Medical device assembly processes

  • Bench test design and testing, including of specialized vascular implant and delivery system

  • Develop collagen processing methods for medical devices

 

 

United States Surgical Corporation, Norwalk, CT (1992-1996)

Technology Manager (1995-1996)

Director of Materials Development, Suture Division (1993-1995)

Project Manager, Suture Division (1992)

 

Technology Manager

Managed new products group, analyzing emerging technologies for synergies with company, including assistance with technical due diligence for potential acquisition of medical device companies/technologies.

 

  • Conducted technical and market research on vascular stents, as well as blood substitutes, artificial kidney and photodynamic therapy

  • Design and prototyping of mini-laparoscopic instruments

  • Co-invented minimally invasive tissue-everting apparatus

  • Thermoplastic extrusion

  • Thermoplastic and thermoset injection molding

  • Ultrasonic welding of thermoplastics

  • Design medical device assembly processes

  • Metals machining processes, including electron discharge machining

 

Director of Materials Development, Suture Division

 

  • Improved and re-released two major suture products: Polysorb® and Surgipro®, including redesign of Polysorb® braid structure and coating and optimization of annealing of Surgipro® polypropylene monofilament sutures

  • Scale-up of production plant and completed 510K testing of new absorbable monofilament suture, Biosyn®

  • Worked with surgeons to test and develop plastic surgery and ophthalmic sutures and needles 

  • Optimization of ophthalmic needle designs

 

Project Manager, Suture Division

 

  • Invented, developed and prototyped synthetic bio-absorbable sternum closure devices that combined buckle design with insert-molded braided straps 

  • Worked with veterinarians to develop ovine in vivo model, using strain gages, for measuring sternal forces during movement modalities

  • Absorbable wound closure textiles and devices

  • Textile braiding, weaving and knitting, absorbable and non-absorbable

 

 

Columbia Dentoform, Long Island City, NY (1990-1991)

Engineering Manager

 

  • Updated thermoset material of tooth model products to decrease shrinkage and increase shelf life

  • Dental models

  • Thermoset injection molding

 

Baxter Healthcare, Valencia, CA (1984-1990)

Project Manager (1989-1990)

  • Thermoplastic extrusion

  • Thermoplastic injection molding

  • Ultrasonic welding of thermoplastics

  • Disposable patient care devices, such as blood warming bags, chest drainage units, hot and cold pads, upper airway suction catheter

  • Design processes for medical device assembly

  • Bench test design and testing

 

Senior Engineer/Engineer (1984-1989)

  • Manufacture process design of quick-connect system for hot/cold pad

  • Worked with specialty plastics design and molding vendor to develop integral o-ring design

  • Managed project portfolio of 100 new product concepts; met with physician inventors to review and evaluate concepts

  • Conceptualized, designed and developed chest drainage unit

 

American Medical Systems, Minnetonka MN (1978-1984)

Engineer

 

  • Invented erectile restoration implant cylinder concept, combining silicone rubber and woven polyester

  • Invented solution to implant wear issue by incorporating ePTFE into silicone rubber device

  • Fecal and urinary continence implantable devices

  • Penile prostheses

  • Silicone rubber liquid injection molding, transfer molding, dip molding and assembly

  • Polyurethane dip molding

  • Invented, designed and built custom penile implants for transsexual and trauma patients

 

Education

 

Stanford University, 1987

Finance for Non-Financial Managers (one week) Seminar

 

Northwestern University, 1978

B.S., Biomedical Engineering, minor in Mechanical Engineering

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