BIOMEDICAL ENGINEER
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PROFILE
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A dynamic, quality, and performance driven engineering professional
with an extraordinary blend of skills spanning the product life
cycle. Recognized for the ability to drive projects to completion.
Skilled collaborator and communicator.
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SKILLS
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Validation & Verification: Planning & Testing
Design & Reengineering
Presentations
Leading and Training Teams
Serviceability: Radiation Therapy Products
Documentation & Reporting
Quality System Development
FDA Regulations
CE Marking Compliance
Literate in Pro/E, LabVIEW 7, GENESIS32
R&D: Respiratory & Anesthesia Products
Product Installation
Customer Training & Support
Reprocessing & Remanufacturing
Code of Federal Regulations (CFR) Title 21
Medical Device Risk Management
Testing Systems & Enhancements
Project Management
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PROFESSIONAL ENGINEERING HIGHLIGHTS
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KAYO TECNOLOGY, Madison, WI
August 2011 - October 2012
*Project Manager
Spearheaded and managed the engineering aspects of a start-up technology
business focused on the design, development, manufacture, and distribution
of an objective measurement and tracking device for the rehabilitation and
physical therapy market.
Led the strategy and implementation of the regulatory and quality
requirements required to obtain FDA 510(k) certification for a class II
medical device.Created, communicated, and managed plans and deliverables
for each phase of the project with limited resources to meet changing needs.
Directed, supervised, supported, and coordinated the internal project
staff and engineering, manufacturing, and quality consultants.
ASCENT: A STRYKER SUSTAINABILITY SOLUTION, Lakeland, FL
August 2010 - July 2011
*R&D/QUALITY PROJECT ENGINEER
Reverse engineer, restore, and release existing surgical devices for
the leader in the industry for reprocessing and remanufacturing, leading
to a more cost effective greener alternative for hospitals.
Oversee, implement, and facilitate design control, regulatory compliance,
and risk management activities related to new product services, sustainment
of existing product services, line extensions, design changes, and
process/quality improvements.
Maintain and facilitate training for all areas of the organization on
department procedures and product/process services, product testing
equipment, and product in-service training.
NEPHRON PHARMACEUTICALS CORPORATION, Orlando, FL
December 2008 - April 2009
*Validation Specialist
Prepared, executed, reviewed, and approved qualification (IQ, OQ, PQ)
and validation documentation in relation to instrument, equipment,
and utilities. Managed validation related deviations.
Reviewed, executed, and approved factory acceptance tests and site
acceptance testing (commissioning) activities. Evaluated
equipment/instrument/service suppliers and approved third party
generated protocols and reports.
TOMOTHERAPY INCORPORATED, Madison, WI
March 2006 - September 2008
*SERVICE DEVELOPMENT ENGINEER
Developed and improved serviceability of the TomoTherapy Hi-Art
treatment system, an integration of computed tomography imaging and
helical intensity-modulated radiation therapy. Interfaced with all
elements of the business. Facilitated the transfer of product designs
into service and recommended and implemented product enhancements
that would improve quality and serviceability, in accordance with
applicable regulations.Created and provided guidance on risks/hazards
and failure modes and effects analysis, FMEA.
Coordinated and conducted pilot site upgrades and component
installations,training clinicians and field service engineers on new
functionality, servicing, and troubleshooting. Ensuring service and
installation documentation was created, validated, and released.
Managed and resolved customer equipment issues, minimizing down time
and disruption to patient therapy. Ensured product support existed
for all installed base products of TomoTherapy product lines
worldwide. Continuously evaluated and monitored data to ensure
product performance specifications were maintained throughout the
product life cycle.
GE HEALTHCARE CLINICAL SYSTEMS LIFE SUPPORT SOLUTIONS, Madison, WI
*BIOMEDICAL ENGINEER II - R&D, VALIDATION & SYSTEMS ENGINEERING
January 2005 - March 2006
Managed system validation and verification of a critical care
ventilator for GE Healthcare as part of GE’s goal to enter
respiratory market after acquisition of Datex-Ohmeda in Fall 2003.
Determined requirements-driven protocols, performing validation and
verification tests using manual and automated test systems and lungs
to simulate patient response to Engstrom Carestation and ongoing
enhancements. Carestation features integrated ventilation with
monitoring modules at the bedside.
Worked with developers and designers new to third party validation
procedures, bringing a process improvement focus to department for
the first time. Passed all FDA and internal audits, with auditors
noting excellent continuity and traceability across all testing
parameters and documentation. Identified new testing methods beyond
scope of current equipment, writing proposal that won funding and
testing agreement with UW Hospitals.
*BIOMEDICAL ENGINEER II - R&D, PRODUCT DEVELOPMENT
October 2003 - January 2005
Managed, coordinated and executed validation/verification and system
per...
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