Ellen Golds' resume:

SUMMARY

Technical consultant with broad medical device industry R&D experience ranging from start up to major corporations.  Consistent accomplishments evidenced by a successful track record of devising and implementing R&D strategies and action plans, managing resource deployment, and developing employee skills.  Responsive leader who builds cohesive teams, delegates responsibilities, and directs technical specialty leaders to achieve goals.

EXPERIENCE

GOLDS ASSOCIATES, LLC (2001-Present)

Consultant to the Medical Device and Pharmaceutical Industries, experience includes: project management; schedule development; critical path assessment for project acceleration; project management training; management consulting; technical assessment and creation of streamlined design control systems.

Partial client list includes ACMI, CSSC, Datascope Intervascular, Enabling Devices, Gerson Lehrman, Organon, Rex Medical and Synectic Engineering.

RENALTECH INTERNATIONAL, LLC (2000)

Director, Product Development

Built polymer and device departments; recruited a manager, 5 engineers, chemist, production

supervisor, 4 technicians; implemented project management.

Managed Polymer Development and Operations, and Device Development Department, with a staff of

16 employees and budgets of over $3 million. 

	Led technical team and contract device manufacturer to build, sterilize, qualify and release for human use, on schedule, the company's first clinical lot of devices.  The clinical trial, in Vicenza, Italy, was successful.
	Hired and led technical team to support Technical Director to develop and automate polymer  process, cutting process material costs by 90% and increasing monthly output 100-fold.
	Led team to create third tier documentation, implement calibration, begin safety training and document training records.  Created detailed budgets for the entire Operations department.

BOSTON SCIENTIFIC CORPORATION (1997-2000)

Manager, Endovascular R&D, Medi-Tech Division

Built department and recruited 6 engineers, 4 technicians, 4 assemblers; obtained financing, designed and led facilities team to build department office, lab and pilot manufacturing space. 

Managed Peripheral Endovascular R&D Department of 5 engineers, 8 support staff: budgets of over $2.5 million.  Led technical group of over 25 people on large project, supported existing endovascular product lines, managed laboratories and machine shop.

	Led technical team from concept through development phases of peripheral endovascular covered stent project, including development of bare stent, coverings and delivery system components.  Product showed improved patency over competing stents in in vivo model.
	Led team to submit over 25 invention disclosures leading to 8 patent applications; five patents have issued to date.
	Ideated and coordinated interdivisional technology sharing including forming relationship with Scimed Division in which Medi-Tech group developed a proprietary extrusion process, while the Scimed group developed a proprietary lamination process.  Both processes were needed by both divisions' projects; neither group had resources to complete more than one.

DATASCOPE CORPORATION (1996-1997)

Manager, Product Development, Collagen Products Division

Managed R&D group and two new projects: future generation Vasoseal® femoral artery closure.

	Conceptualized, built and tested prototypes in vitro and in vivo to find mechanical and bio-active improvements to the Vasoseal® collagen product.
	Wrote ISO design control documentation to assist upper management in defining and implementing a new system.

UNITED STATES SURGICAL CORPORATION (1992-1996)

Technology Manager, Auto-Suture Division (1995-1996)

Managed concept phase projects; transferred to development group.  Assessed new technologies.

	Led team in design and prototyping of 2mm Ob-Gyn mini-laparoscopic instruments.  Prototypes were shown at the '95 American College of Surgeons meeting within 3 months of project start.  Instruments released for sale 2Q'96.
	Conducted technical and market research and reported on new technologies: blood substitutes, artificial kidney, vascular stents and photodynamic therapy.

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

Managed Materials Development department of two managers, four engineers and five technicians with a budget of $2 million.  Optimized existing suture and patch products and their manufacture; led new product development.

	Finalized development, scaled-up production plant and completed 510K testing of new absorbable monofilament suture, Biosyn(r); released for sale Q3'95.
	Improved and re-released two major suture products: Polysorb(r) and Surgipro(r).

Project Manager, Suture Division (1992)

Invented, prototyped and developed synthetic absorbable sternum closure devices.

COLUMBIA DENTOFORM (1990-1991)

Engineering Manager

Managed R&D, Manufacturing, QC and Facilities Engineering. 

	Updated thermoset material of tooth model product; decreased shrinkage and increased shelf life.
	Created QC department, decreased rejects and customer complaints.

BAXTER HEALTHCARE (1984-1990)

Project Manager, Pharmaseal Division (1989-1990)

Led team on difficult "buy-in" upper-airway suction catheter scale-up at Puerto Rico plant.  Team turned around project that previously lost $200K in bad manufacture.

Senior Engineer, Pharmaseal Division (1986-1989)

	Moved new quick-connect system for hot/cold pad from concept into manufacturing.  Design had best field trial results in Pharmaseal history.
	Managed a 100 project portfolio; transferred eight projects into R&D.

Engineer, Pharmaseal Division (1984-1986)

Conceptualized, designed and developed chest drainage unit based on my direct market research.

AMERICAN MEDICAL SYSTEMS (1978-1984)

Engineer (1983-1984)

Associate Engineer (1978-1983) 

Led interdisciplinary project development teams, supported manufacturing and managed custom device line.

EDUCATION

Stanford University, 1987

Finance for Non-Financial Managers Seminar

Northwestern University, 1978

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

MEMBERSHIPS

American Society of Mechanical Engineers

Society of Women Engineers

PATENTS

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

Absorbable Sternum Closure Buckle, US 5,356,417

Suture Loop Locking Device, US 5,383,905

Tissue Everting Apparatus and Method, US 5,976,161

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

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

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

Stent Delivery System with Nested Stabilizer and Method of Loading and Using Same, US 6,607,551

Mesh and Stent for Increased Flexibility, US 6,673,103

Intraluminal Stent, US 6,730,117

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

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

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 ?2-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

Page design by Ellen Golds, last updated 20070724