EXPERIENCE:
Consultant – New Product Development and Design Controls / Regulatory Compliance and Risk Management
January 2017 – Present
- Drug Delivery/Combination Products: Assuring design controls, cGMP and risk management compliance with ISO 13485, 21 CFR 820, CFR Part 4 and ISO 14971 while managing projects, overseeing project leaders and leading documentation development for mechanical and electromechanical insulin infusion systems and implantable combination products; Audited local and offshore CMO’s; Providing Business Development support for applications and funding of new drug delivery technologies; Developed design transfer procedures –Valeritas, Marlborough, MA, Insulet Corp., Bedford, MA, Taris Biomedical, Lexington, MA, Suono Bio, Cambridge, MA
- Monitoring and Imaging: Executed extensive reviews of DHFs for evidence of Design Controls compliance per ISO 13485:2016 and 21 CFR 820 and performed similar file reviews for Risk Management compliance per EN ISO 14971:2012; Completed regulatory and standards gap analyses for Design Controls and Risk Management process conformance; Developed proposal for improved Design Controls compliance; Created new, comprehensive Risk Management process for corporate business group. – Philips Medical, Andover, MA
- Cardiology: Led projects and provided design and technical guidance for mitral valve regurgitation therapy implants and delivery catheters; Revised polymer component designs and processes per DFMA principals to eliminate defects and reduce costs; Managed reliability testing – Cardio Solutions, Inc., West Bridgewater, MA
Vice President, Development and Manufacturing, Rinovum Women’s Health, LLC, Monroeville, PA
April 2011 – December, 2016
- Responsibilities: Product Development, Q&R Compliance, Project Management, CMO/Vendor Contracts, IP
- Created initial QMS and managed original purchasing, receiving, inspection and overall operations activities
- Managed DHF’s & Design Controls compliance; Developed FMEA’s and risk analyses for process, design & use
- Established specifications with KOL’s and developed concepts for “The Stork” conception assist system
- Managed and guided injection molding and assembly vendors through process development, process validation and manufacturing cycles to assure on-time, continuous availability of product
- Planned and managed development and manufacturing projects and budgets to meet tight timing and cost targets
- Designed and patented “The Stork’s” delivery and implantable systems; Designed all injection molded and LIM silicone components with DFMA focus; Led new product concept generation; Managed IP submissions
- Selected and negotiated agreements with critical supply chain members for early and long-term manufacturing
Senior Director of R&D, Den-Mat Holdings, LLC, Santa Maria, CA
December 2009 – April 2011
- Responsibilities: R&D Management, Q&R Compliance, Project Management, NPD, Production Planning, IP
- Established 21 CFR 820 and ISO 13485 compliant Design Control, New Product Development and DHF processes leading to “no findings” during FDA and ISO compliance audits
- Implemented company’s first design verification, design validation, reliability and process qualification activities
- Managed and mentored large R&D team of scientists and engineers through rapid development, manufacturing and 510(k) clearances of bio-polymers and two IEC-60601 compliant laser surgical systems
- Supervised and mentored project managers; Collaborated with marketing to assure proper manufacturing cycles
- Staffed and led cross-functional project teams and external electronic, software and usability design partners
- Selected, negotiated contracts with and managed design transfer and validation for injection molding vendors
Director of Engineering, Pervasis Therapeutics, Inc., Cambridge, MA
November 2006 – November 2009
- Responsibilities: Combination Product Development, QMS Procedures, Manufacturing Management, Partnerships
- Established Quality Management System procedures for device design controls, validation and manufacturing
- Identified and established partnerships, quality contracts and manufacturing agreements with critical suppliers
- Led cross-functional team in development of formulations and delivery device for novel bio-therapeutic
- Managed scientists and engineers; Performed Clinical Research with KOL’s and developed both percutaneous and trans-catheter methods for ultrasonic imaging-guided, perivascular injection of cell-based live-tissue implants
R&D Manager, Medtronic / angioLINK, Inc., Taunton, MA (angioLINK, acquired by Medtronic in 2004)
October 1999 – October 2006
- Responsibilities: R&D Management, Product Development, QMS Procedures, Project Management
- Established design requirements with KOL’s and marketing for disposable, catheter-access vascular closure implant system (VCS); Created Design controls and manufacturing SOP’s; Managed design control compliance
- Planned & managed projects, cross-functional teams, design verification, design validation and pre-clinical studies
- Developed and patented novel concepts for blind vascular access and implant delivery; Performed design & FEA
- Hired, managed and mentored R&D / manufacturing team; Led team through Medtronic acquisition transition
- Identified and initiated contracts with injection molders and other suppliers; Managed design transfer & validation
Staff Engineer/Project Leader, R & D, Mentor Medical, Inc., Norwell, MA
March 1996 - May 1999
- Managed electro-mechanical design teams for ultrasonic generator, irrigation pump, aspirator and disposables for ultrasonically-assisted lipoplasty system with DFMA emphasis; Performed design and Finite Element Analyses
R & D Design Engineer and New Business Technologies Investigator, ILC Dover, Frederica, DE
February 1992 - March 1996
- Created computer simulation models for the design, analysis and development of impact attenuation system (”air bags”) responsible for successful landing of NASA’s Mars Pathfinders and managed new technology programs
Design/Project Engineer, Ohmeda Critical Care (BOC Group), Columbia, MD
August 1989 - February 1992
- Managed critical infant care electro-mechanical projects; Sustaining Engineering; Project management training
EDUCATION:
- MBA, University of Massachusetts, Isenberg School of Management, 2019
- B.S. MECHANICAL ENGINEERING, University of Akron, Akron OH, 1989
- DENTISTRY (partial program completion), Ohio State University College of Dentistry, Columbus, OH, 1984 - 1987
- B.A. CHEMISTRY, University of Akron, Akron, OH, 1984
ADDITIONAL TRAINING (highlights):
- Managing Technical Professionals and Organizations – MIT Sloan School of Management
- Design for Manufacture and Assembly (DFMA) - Boothroyd Dewhurst, Inc.
- ANSYS (Finite Element Analysis, linear and non-linear analysis) – Ansys East
ENGINEERING SOFTWARE EXPERIENCE (partial list):
- CAD - SolidWorks, AutoCAD, Pro-Engineer, Boothroyd Dewhurst DFMA
- FEA – ANSYS Classic, ANSYS Workbench, COSMOSXpress
- Project Management – Microsoft Project
PATENT HISTORY:
(US only) 6322580, 6348064, 6506210, 6533762, 6755842, 6767356, 7074232, 7198631, 7597706, 7758610, 8551134, 8192347, 9,289,297, 9,770,263; Applications: 20100185156, 20180021120; Provisional: 62651499