James J. Sullivan
Current location: West Boylston, MA
I am Designer/Engineer with 15+ years of experience in the medical device industry. My responsibilities included working side by side with leading surgeons to design and develop minimally invasive medical devices for the arthroscopic repair of sports related injuries.
CAD – SolidWorks
ANSI Y14.5 GD & T and Drawing Standards
FDA 21 CFR Part 820, ISO 9001
Process Validation Requirements and Industry Practice (AAMI course)
The WPI Project Management Certificate Program
Design for Manufacturability (WPI seminar)
Project Risk Management (WPI seminar)
Fundamentals of project Management for manufacturing Professionals (WPI seminar)
Microsoft Project 2000 Workshop (WPI seminar)
Process Mapping (WPI seminar)
DoE workshop (WPI seminar)
Anatomy & Physiology (seminar)
BD Medical, Billerica, MA Jan 2012 – Present
Created DIRs (document information records) and maintained SAP database with ECR/O process.
Support the design team during the development phase of Subcutaneous and Intradermal Infusion Sets for Type I Diabetes patients.
Responsible for creating alternative design of plastic injection molded components for preliminary testing.
Created inspection and test fixtures to support verification testing and inspection processes.
In charge of creating and maintaining all component, assembly and BOM specifications during the development phase of the project.
Designed packaging for product including fixtures for packaging assemblies and thermoform sealing.
Performed tolerance studies of mating components and assemblies with an emphasis on design for manufacturability.
Package Portion for a Medical Product, App. No. 29/449,331
Package for a Medical Product, App. No. 13/830,009
Needle Guard, App. No. 61/19,755
Infusion Device with Releaseable Fluid Connector PCT/US12/68632
Smith + Nephew, Mansfield, MA May 1997 – Jun 2011
Development Engineer II
Responsible for the design and development of reusable and disposable arthroscopic medical instruments from concept to finished product. All products are designed based on the user needs of the customer.
Strong understanding of Design Controls and FDA regulations for reusable medical devices.
R&D lead on new product development teams.
Responsible for creating and maintaining the project Design History File, creating and maintaining the design specifications, and working with internal and external vendors to manufacture parts and assemblies for proof of principle and feasibility studies.
Perform Design FMEA’s, generate test procedures, etc… per internal Design Control Procedures.
As the R&D lead, coordinated meetings with core team members to maintain focus and track progress of the project.
All designs and layouts are generated on SolidWorks.
R&D representative for the Calibration Task Force.
Mansfield representative for the Smith & Nephew Drafting Standards Team.
System for use in Tissue Repair, PT-3757
Surgical Fastening – US Serno. 13/21366
PT-3784 Advanced Suture Passer
PT-3758 Cannulated Steerable Guide
Instrumentation and Technique for Anchor Implantation
Pound-in Suture Anchor System
External Suture Slot Anchor Geometry
Mechanical Designer, Transfusion Technologies Corporation, Natick, MA 1995 – 1996
Responsible for design and packaging of blood processing equipment.
Also responsible for the design and manufacture of test and alignment fixtures.
Assigned to work with manufacturing in the redesign of components for better cost savings and ease of assembly.
All layouts and designs were created using AutoCad Release 12 with AME.
Mechanical Designer, Candela Laser Corporation, Wayland, MA 1991 – 1995
Responsible for design and packaging of medical laser systems in collaboration with marketing, manufacturing, and field service departments.
Designs and layouts were created as three dimensional solid models using AutoCad Release 12 with AME.
Delegated drafting assignments, including details, assembly drawings, and bills of material.
Worked with vendors to determine cost and delivery dates for prototype parts.