MY SERVICES

I am ready to support you through every step of the medical product development process, leveraging scientific, clinical and commercial expertise to help you maximize value at each stage.

Development Strategy

  • Assist clients with a "Conecpt to Market" strategy based on the statutory requirements dictated by FDA and for CE Mark

  • Establish a Design History File (DHF) containing the records necessary to demonstrate that the design was developed in accordance with the approved design plan



Design & Engineering

  • Maximize client and user input to design for efficiency and cost effectiveness without sacrificing aesthetics

  • Engineering capabilities include: structural and thermal analysis, technology evaluation, fully parametric modeling, design for injection molding, packaging, and QC drawings to GD&T standards


Project Managment

  • Develop project timelines and resourse allocation for each development phase

  • Establish effective communication channels between management, engineering, manufacturing, marketing, and other functional areas

  • Develop breakdown structure work packages including newtwork diagrams, Gantt charts, and flow diagrams

Design of Experiments

  • Development of bench, animal and clinical testing protocols, justify sample size requirements, and interpretation of results

  • Identification and implementation of necessary general control standards and procedural regulations (ISO, ASTM, IEC, etc.)

  • Provide startegy and test requirements for biocompatibility, sterilization, aging, ship studies, etc.

Report Writing

  • Provide technical reports which include statstical analysis, diagrams, and references when necessary

  • Provide FDA and CE Mark friendly formatting for all technical reports to ensure expeditious review




Regulatory Affairs

  • Prepare or assist in the preparation of regulatory submissions for medical devices, including: 510(k)s, PMAs, IDEs, de novos, Pre-Submissions, HDEs, 513gs and RFDs

  • Offer FDA and Notified Body advisory panel preparation and meeting support

  • Assist with responding to FDA deficiency letters and informal/formal communications


MY PORTFOLIO

  • All
  • Devices
  • Patents
  • Part Design
  • Clinical Studies
  • Regulatory
  • Data Analysis
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REVOLUTION
Peripheral Atherectomy System

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CLEANER XT / CLEANER 15
Rotational Thrombectomy System

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MOLDED PARTS

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PROTOTYPE PARTS

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REVEAL CLINICAL STUDY
NCT02961894

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REGULATORY

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DATA ANALYSIS

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PATENTS

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TECHNICAL DRAWINGS

ABOUT ME

I have over 12 years of experience in R&D, Product Design, Regulatory Affairs, and Manufacturing Operations. I started my career at a medical device startup where he held positions as both Senior Development Engineer and Project Leader simultaneously. This has allowed me to take a lead role in projects from immersion and concept generation through to detailed design, development, and commercialization. My background in biomedical engineering enables me to balance user requirements with technical and biological considerations whilst developing commercially viable products.

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Education

Bachelor of Science in Biomedical Engineering

Drexel University, School of Biomedical Engineering and Health Systems

Experience

Rex Medical

Project Leader & Senior Development Engineer (2015-Current)
Development Engineer (2012-2015)
Medical Device R&D Intern (2010-2012)


Kensey Nash Corporation

Polymer Manufacturing Engineering Intern (2008-2010)

Skills

  • Product development from concept generation & prototyping to product launch
  • Project management
  • Quality assurance
  • Electromechanical & Biomechanical aptitude
  • Qualitative and quantitative research methodology
  • Client presentations
  • DOE, test protocol and report creation
  • Create and monitor project budget and spending
  • ProEngineer/Creo/Solidworks, MS Office Suite + Visio, MS Project, Minitab, LabView, Adobe Suite
  • Download My Resume

    CONTACT ME

    If you have questions or would like more information, please email me.