- New medical device product development and transfer to manufacturing.
- Compliance consulting to medical device and pharmaceutical clients.
- Writing and executing validation documents for new medical device facilities.
- Remediation of 483 and warning letters.
- Thorough knowledge of FDA regulations with particular expertise in design controls, controlled documentation, validations and change control.
- Project management expert.
Undisclosed Company, Senior Consultant, 2001 - Present
- Pharmaceutical consultant for clients on remediation of 483 observations.
- Prepare response to FDA, including commitment for monthly updates toward final remediation.
- Managing client efforts to achieve commitments and submitted monthly updates. Member of four person core team that restructured equipment company's procedures for compliance to QSRs.
- Design controls and purchasing controls.
- Lead consultant/client team in auditing of numerous DHF and PMA files for FDA compliance.
- Coordinating remediation, as required, making recommendations for restructuring design control procedures to streamline development cycle while maintaining QSR compliance.
- Writing and executing validation documents for new $150 million device facility.
- Develop new structure and procedures for change control and vendor qualification.
Fresenius Medical Care, McAllen, TX /Reynosa, Mexico, Product Engineering Manager, 1993 - 2001
- Lead division recovery team that implemented change of all product documentation, a major part of the project that lead to the lifting of FDA import ban on bloodlines.
- Facilitated improved communications between plants and division headquarter following lifting of import ban, resulting in improved plant issues.
- Coordinated transfer of product engineering from Rockleigh, New Jersey to McAllen, Texas and, thereafter, to Reynosa, Mexico.
- Built and managed team responsible for new product development, product improvements, cost reductions and the investigation and resolution of customer complaints.
- Developed bloodlines product line to world class standard with leading market share and annual sales of 25 million units, while implementing $6 million in cost reductions.
- Managed Product Engineering Laboratory and AutoCAD services.
- Provided technical input and responses to FDA for numerous successful 510(k) submissions.
Independent Consultant, 1990 - 1993 and 1984 - 1989
- Conceptual design of internal stapling medical device.
- Project management of an advanced hearing aid.
- Development of emergency medicine and surgical devices.
Sheridan Catheter Corporation, Argyle, NY, Senior Project Engineer / Supervisor, 1989 - 1990
- Managed the design and development of company and OEM devices.
- Supervised project engineers with responsibility for OEM extruded devices.
- Developed project plan, including project schedule and capital budget, for tracheotomy tube product line offering significant clinical advantages.
Deknatel (Pfizer), Floral Park, NY, Project Manager, 1981 - 1984
- Managed medical device projects utilizing small in-house staff and team of external designers, engineers, and contract manufacturers.
- Managed development of a line of surgical skin staplers and extractors, budgeted at over $1 million in development costs.
- Managed additional projects in closed wound drainage and chest drainage.
- Acted as division internal consultant for plastic and plastic processing.
Bard-Parker (Becton-Dickinson), Lincoln Park, NJ, Senior Project Leader, 1973 - 1980
- Within a matrix management organization, managed critical new product development projects resulting in the launch of major product lines.
- Managed design and development of pre-filled humidifier and nebulizer product line allowing company to regain leading market share in humidifiers and nebulizers.
- Managed development of a line of arterial blood gas sampling kits that attained a 25% market share in an established competitive market.
- For pre-fills and blood gas kit product lines, provided engineering support and technical sales training; prepared product graphics, sales aids and promotional materials.
- Lead multidisciplinary task force that solved major product failure problem with no interruption in sales.
Honors & Publications
- Process Validation Solutions
- Effective Complaint Handling
- CAPA Systems
- FDA Design Control
- Kepner-Tregoe Problem Solving/Decision Making
- Customer Relations
- Human Physiology
- Plastic Part Design and, Mold Design
- Advanced Project Management
- Bioengineering Polymers
- Value Engineering
- Medical Packaging and Sterilization
- Finance for Non-Financial Executives
- MODAPTS Work Measurement System
- Fast Track to PRO/Engineer Wildfire.
MBA Management, Baruch College, New York, NY
B.S. Chemical Engineering, City College of New York, New York, NY