Resume

Ellen M. Golds

Technical and project management consultant with extensive medical device industry R&D and quality compliance experience
Successful track record of devising and implementing compliance and R&D strategies and action plans, managing resource deployment, and developing employee skills
Responsive leader with experience building cohesive teams, delegating responsibilities, and directing technical specialty leaders to achieve goals

Experience

Golds Associates, LLC, Hastings on Hudson, NY (2001-present)
Medical device and pharmaceutical project management consulting company

Founder and Principal
Founded consulting company to help clients progress medical device product development using project management tools that comply with ISO and FDA design control systems. Practice has expanded to include regulatory compliance projects and expert witness work.

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, prepared minutes with action items, created metrics and reports. Efforts focused on process validation, MDR, gages, purchasing and CAPA. Prepared slides for and attended weekly executive management review of the 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. 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.
Assisted world-wide medical device manufacturer with R&D integration of international medical device acquisition, subcontracting with larger consulting firm. Reporting to project management office for the integration of the R&D department, created schedules, project reports, and proposed organizational charts. Interviewed acquisition R&D employees in retention effort.
Turned around critical pharmaceutical packaging line validation for service provider, who risked losing a contract of more than 30 projects with its biggest client because this project was 3 months behind schedule. Under my management, the team completed the initial qualification phase of the project on schedule. Results showed the process was not qualifiable, but timely completion allowed client to save money, and the service provider maintained the business.
Created and implemented a training module that taught Work Breakdown Structures (WBS) and Gantt charts for mid-size minimally invasive medical device company employees.
The same mid-size medical device company’s fast-track project was stalled by an inexperienced project manager. Worked on site leading the team for several months to coordinate between R&D and manufacturing, ensured documentation was completed, created up-to-date minutes with action items, and a schedule. Returned the near-completed project to the original project manager.
Expert witness case: determined whether a new product development effort had been delayed by inappropriate conduct. Using project management expertise, reviewed thousands of project and company documents and created a forensic project timeline, showing that the product development project proceeded in a timely fashion and without gaps. Substantiated from external data that the client company’s competitors’ new product projects were slower than the project at issue. Reportedly, Judge said that after reading my report, he valued the other side’s claim at zero; attorney client said my report blew the other side out of the water. Case settled in my client’s favor.
Expert witness case: a medical device manufacturer was being sued by a minority owner/ex-employee for oppression under state law. During the discovery phase, it was found that the plaintiff had started a possibly competing business, contradictory to his certification. Performed an inspection of the alleged competing business, and then met with the magistrate to report preliminary findings. Showed evidence that the plaintiff had been untruthful in his certification. The case settled after plaintiff reduced his demand by several hundred thousand dollars.

Validant, San Francisco, CA (2011-2012)
Life sciences technology consulting company

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

AlvaMed, LLC, Waltham, MA (2004-2008)
Medical technology consulting company

Vice President, Product Development & Project Management
Quality and regulatory compliance focused consultancy that supports small-to-world-wide medical device companies’ engineering and product development efforts. As VP of Project Management, managed company’s projects internally, and managed consultant, client and combined project teams for clients, managed client relationships, sales and proposal process, participated in marketing efforts.

Performed technical support work and review of deliverable documents in vascular and cardiovascular implants and delivery devices, minimally invasive medical devices and absorbable wound closure.
Doubled sales yearly for the past 3 years; 2007 sales were more than $850,000.
Led a process validation team of 7 consultants and numerous client team members located on both coasts and outside of the US, while managing the world-wide medical device client, and the successful validation and process transfer internally for AlvaMed.
Participated in new product brainstorm session led by small medical device company.
Led a project a team of 6 engineers to efficiently create input phase documentation for two implantable vascular product projects for large medical device company division within schedule.
Led a team composed of a mix of AlvaMed and client engineers to generate missing vascular device design control elements for a manufacturer of invasive therapeutic products unable to adequately respond to an MDR reportable event. Provided resource plans, schedules and reports. The resulting DHF enabled the company to adequately respond to FDA.
Managed an AlvaMed project manager, who led an integrated client and consultant team to discover that the root cause of project stalled in validation phase was improper polymer resin selection by the client. Provided engineering review of the deliverable documentation. The project was reverted to the design phase; the company saved money and risk by not proceeding with a flawed product.
Led a team of designers and component suppliers to reduce cardiac implant IP to practice in just 4 months for a world famous university research hospital. Client successfully licensed IP.
Led a team of 4 AlvaMed engineers to complete the concept phase of next generation cardiac device in 4 months for start-up. AlvaMed team worked through all phases from initial brainstorming, through design and prototyping to in-vivo testing, and documentation. Also managed a novel implant project at the same client, created project strategies based on critical path analysis of prototype schedules which led upper management to realign project priortities.
Wrote expert witness report to support patent case; resulting favorable Markman decision lead to cash settlement for my client.

Renaltech International, LLC, New York, NY (2000)
Blood filtration device start up company
Director, Product Development

Built polymer and device development 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 more than $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, Wayne, NJ (1997-2000)
Manufacturer of medical devices that advance the practice of less invasive medicine

Manager, Endovascular Peripheral R&D, Meditech 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 with budgets of over $2.5 million.
Led technical group of more than 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 lumen patency over competing stents in in vivo model.
Led team to submit over 25 invention disclosures leading to nine US patents 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, Montvale, NJ (1996-1997)
Manufacturer of medical devices

Manager, Product Development, Collagen Products Division

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 design control system.

United States Surgical Corporation, Norwalk, CT (1992-1996)
Manufacturer of medical devices that advance the practice of less invasive medicine

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

Led team to design and prototype 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)

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

Project Manager, Suture Division (1992)

Invented, prototyped and developed synthetic absorbable sternum closure devices.

Columbia Dentoform, Long Island City, NY (1990-1991)
Manufacturer of educational dentoforms

Engineering Manager

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

Baxter Healthcare, Valencia, CA (1984-1990)
Pharmaseal Division, Medical Device Manufacturer

Project Manager (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 (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 project portfolio of 100 new product concepts; transferred eight projects into R&D.

Engineer (1984-1986)

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

Education

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

Stanford University, Finance for Non-Financial Managers (one week seminar)

U.S. Patents

  5,356,412 Sternum Buckle with Rotational Engagement and Method of Closure
  5,356,417 Absorbable Sternum Closure Buckle
  5,383,905 Suture Loop Locking Device
  5,976,161 Tissue Everting Apparatus and Method
  6,001,125 PTFE Vascular Prosthesis and Method of Manufacture
  6,312,458 Tubular Structure/Stent/Stent Securement Member
  6,533,806 Balloon Yielded Delivery System and Endovascular Graft Design for Easy Deployment
  6,607,551 Stent Delivery System with Nested Stabilizer
  6,673,103 Mesh and Stent for Increased Flexibility
  6,730,117 Intraluminal Stent
  6,881,221 Tubular Structure/Stent/Stent Securement Member
  7,186,263 Mesh Graft and Stent for Increased Flexibility
  7,867,267 Stent Delivery System With Nested Stabilizer and Method of Loading and Using Same
8,048,138 Medical Device Retaining Sheath and Medical Device Delivery System

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

Professional Memberships
  American Society of Mechanical Engineers Heathcare Businesswomen's Association
  Society of Women Engineers