R&D & Operations Leader and RA/QA Consultant


R&D and Operations strategic leader and regulatory/quality consultant with extensive medical device and combination product experience in large organizations and successful entrepreneurial ventures. Strong background in regulatory, quality and risk management compliance. Exceptional creative abilities applicable to: resolution of process, quality and managerial challenges, efficient project management, product development and agreement / contract negotiations.

  • Mechanical Engineer (BS) and Chemist (BA) with MBA and post-grad study in biochemistry & physiology
  • 20+ years leading device and combination product development, Q&R and manufacturing projects and teams
  • Class II and III medical device background in drug delivery, software-driven electro-mechanical and energy-based surgical systems, combination products, silicone and titanium implants and cardiovascular therapies 
  • Expert in design controls, R&D regulatory compliance, Design History File (DHF) creation and risk management
  • Highly experienced with ISO 13485:2016, 21 CFR 820, MDD, CMDR and EN ISO 14971:2012 conformance
  • Background in leadership and support of 510(k), PMA, IDE, IND and NDA submissions and CE mark certification 
  • Strong team leadership, staff development, mentoring, inter-functional communication and negotiation skills
  • Highly experienced in strategically driving cross-functional teams through rapid product development cycles
  • Experienced in the creation of comprehensive business plans and supporting budgets
  • Extensive background in rapid and cost-effective manufacturing start-up, CMO selection, compliant design transfer 
  • Proven talent for initiating innovative and highly-manufacturable design concepts (DFMA/DFS Champion)
  • Highly proficient with design (SolidWorks) software; Finite Element Analysis (FEA – ANSYS) experience
  • Significant background in intellectual property management and effective patent creation and submission


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


  • 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


  • 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


  • CAD - SolidWorks, AutoCAD, Pro-Engineer, Boothroyd Dewhurst DFMA
  • FEA – ANSYS Classic, ANSYS Workbench, COSMOSXpress
  • Project Management – Microsoft Project


(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

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