Product Development Quality Engineer
Resume:
Kenneth Burnap
** **** ***** **** *******, MA ***18
*******@*****.***
EDUCATION:
Wentworth Institute of Technology
Bachelor’s degree 5/2003 BDEM, Mechanical Design Engineering
Associate’s degree 5/1998 ELEM, Electromechanical Engineering
CORE COMPETENCIES:
Solidworks ERP/MRB Root Cause Analysis
DMAIC Lean Product Development
Kaizen Process Validation AutoCAD
MS Project Sharepoint IFS
MS Office UNIX Sun work stations Oracle
Patents:
U.S. Patent 9280654- Battery Authentication Circuit
EXPERIENCE:
General Dynamics(Bluefin Robotics) 12/2016-Present
Program Quality Engineer:
●Designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
●Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment and finished products
●Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary
●Reviews Documents/Drawings/Instructions for conformance to requirements
●Compares defects against standards and recommends dispositions, and verifies implementation of rework
●Collects, organizes and analyzes project data, generates and/or reviews metrics
●Performs audits, assigns corrective action, and verifies implementation
●Participates in project reviews and meetings including technical design reviews, technical peer reviews
Cadence Inc 5/2015-10/2016
Senior Project Engineer:
●Responsible for managing companies strategic medical accounts (Covidien, Medtronic, etc.). Various new custom injection molding product development projects from feasibility and design through production ramp up.
●Design, sourced and coordinated new 1600 square foot ISO 8 cleanroom. ISO 8 cleanroom to be used for strategic medical customers.
●Led a cross functional group through various projects to meet critical company goals and timelines.
●Completely revamped company’s product development procedure as well as quoting procedures.
Electrochem Solutions(Greatbatch) 3/2012-5/2015
Senior Product Development Engineer/Project Manager:
●Responsible and accountable for the coordinated management of multiple class 2 and 3 medical device development projects for FDA approval directed toward strategic business.
●Directly worked with customer project team and management to fully define medical device requirements and statement of work to be performed for new multi-million dollar development projects.
●Assisted sales and applications with developing proposals for new power solutions and rechargeable battery packs.
●Successfully led multidiscipline team through complex gate development process in creation of specifications and designs of battery packs to meet customer requirements.
●Setup and tracked project details in MS project and manage project dependencies to critical path to ensure timely verification and validation for FDA approval.
●Sourced material through various domestic and international suppliers to support development and future production.
●Successfully drove new medical devices through verification and validation with consideration to risk management.
●Managed transfer of products to production from engineering after completion of regulatory testing and approval.
●Coordinated project status with project stakeholders and published regular comprehensive project / program status reports.
●Maintained continuous alignment of program scope with statement of work, and made recommendations to modify the program to enhance effectiveness.
●Executed and maintained program management processes and disciplines in the areas of: program schedule, quality management, cost management; procurement management; risk / issue management; change management.
IDEX Health and Science (Sapphire Engineering) 7/2007-12/2011
Mechanical Design Engineer:
●Responsible for product development of precision dispense pumps used in the medical, analytical and diagnostic instruments. Also involved in various High Pressure Liquid Chromatography (HPLC) check valve designs up to 20k psi.
●Acted as initial engineering contact and customer liaison for all new pump related projects. Key responsibilities include working with customers to determine their pump application. Determine which pump product was needed to meet their requirements.
●Create initial design specifications using various tools and Solidworks before presenting to customer for approval.
●Designs met various customer requirements and specifications such as flow rates, pressure, temperature and lifetime.
●Upon final design, all part numbers, bill of materials and out sourced components are quoted, established and put into MRP system.
●Successfully brought multiple projects through gate process verification, validation and customer approval. Three complete product launches from initial concept to production release for high profile customers.
●Daily work performed including generating part numbers; BOM’s and detailed drawings for new designs using Solidworks.
●Developed and performed all testing in engineering lab to support products both in prototype stage and production.
●Leader in implementing the New Product Development Process into the organization and training other groups on new processes as well as new software and tools.
●Regular leader and team member for ECN events and continuous improvement efforts throughout the company including various kaizen activities.
●Worked closely with the machine shop and production floor regularly to support them for both production and prototype manufacturing.
ADE Corporation 2/2000 – 5/2006
Lead Test Engineer:
●Work proficiently on company’s main product line of silicon wafer inspection systems. Using various scopes, meters and measuring devices to setup system.
●Responsible for creating and presenting final validation data package to customers around the world, using various MS software utilities.
●Other lead duties were to instruct six technicians, coordinate schedule with management, and provide design solutions to Engineering and assist customer support with issues in the field at wafer fabrication plants.
●Performed diversified duties of final assembly, test, troubleshoot and repair of electronic, mechanical and optical systems and sub systems.
●Worked from specs, tech manuals, schematics, and/or written/verbal instruction.
●Wrote all procedures to test for quality per ISO 9001 standards. Perform incoming quality inspection of silicon wafers within a class 10 clean room. Reduced cycle time from 3 months to 3 weeks on main product line.
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