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<pre>Array ( [var] => cut_url ) </pre> Resume for Matthew B. for Editor / Writer / Publisher / Biotechnology & Pharmaceuticals in Loveland, Colorado. Search More Resumes for Editor / Writer / Publisher on Resumark.com #PJT9LUXP3
 

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Resume for Matthew B. for Editor / Writer / Publisher / Biotechnology & Pharmaceuticals in Loveland, Colorado




Occupation: Editor / Writer / Publisher Industry: Biotechnology & Pharmaceuticals
Country: United States City: Loveland
State: Colorado ZIP: 80537



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Matthew B.
Email:
S. Saint Louis Ave.
Loveland, CO
Summary
Six and a half years working in the production of medical devices: digital scanning microscope, automated
slide stainer, flow cytometers.
Five years developing process validation installation qualification, operational qualification and process
qualification protocols and reports to meet FDA regulatory requirements from CFR part .
Originating and championing engineering change orders in Agile PLM to close deviations, meet customer
expectations and release new products.
Creating and maintaining controlled documents in accordance with established standards.
Software: Microsoft Word, Microsoft Power Point, Microsoft Excel, Agile PLM, Outlook, Access, Share
Point, Visio, HTML, Cascading Style Sheets, Perl
Excellent communication skills, both written and verbal, across all departments.
Work Experience
Adecco USA Inc.
August November
Operations Engineer
Contract position at Beckman Coulter, Inc. supporting the release and production of medical devices: flow
cytometer line.
Originate and structure engineering change orders in Agile PLM to release new revisions of controlled
documents, restructure bill of materials, and implement design changes.
Update controlled documents with design changes and process improvements.
Used Share Point to gather assembly issues and publish documents for new line.
Wrote Quality System procedure for releasing instruments from manufacturing.
Inspected batches of dichroic filters for orientation of optical element mounted in holder.
Beckman Coulter, Inc.
January December
Senior Technical Operations Technician
Member of technical operations staff supporting the production of medical devices: flow cytometers.
Provided technical solutions for process related issues and questions to keep production running smoothly.
Prioritized time across multiple projects and managed expectations according to the current priorities.
Created and maintained revision controlled documentation in MS Power Point and Word, working with
Document Control and adhering to applicable Quality System requirements in accordance with ISO
standards. This involved working with both R&D and Production to capture all of the relevant information.
Documentation included text with accompanying photos, drawings, screen captures and solid models.
Edited documents to ensure their accuracy and completeness as well as working to improve the
documents structure and flow.
Attended meeting and interviewed subject mater experts to gather information to develop technical
documents.
Developed process validation installation qualification, operational qualification and process qualification
protocols in Microsoft Word to meet FDA regulatory requirements from CFR part . Managed
execution, and implemented improvements to the process. Documented and summarized results of
process validation in subsequent reports.
Gathered data during the execution of process validation protocols and used Microsoft Excel to organize it
into charts and tables for analysis.
Championed engineering change orders from creation to implementation in Agile product lifecycle
management database to resolve deviations, meet customer expectations and release new products.
In Oracle, setup pull sequences for new items and updated quantities for existing items as part of
implementation for engineering change orders
Investigated and researched the role of optical elements to properly document cleaning, handling,
mounting and installation.
Created format for TQC work instructions to move assembly verification points upstream and reduce time
for Quality Control inspection.
Reduced assembly time from to . days by collaborating with Lean Manufacturing Engineer to lay out
production line and update documentation for continuous flow.
Researched the cost and resources required to implement three different software packages to streamline
the creation of assembly work instructions. Made a final recommendation with a price of $ compared
to initial estimate of $, to $,. After approval and purchase of the software, created a template
and wrote the technical procedure for producing work instructions with the software.
Participated in design for manufacturing reviews and worked with Quality Control Manager on PFMEAs.
Wrote deviations for one time custom features to meet customer requests.
Initiated, justified and implemented new equipment purchases for process implementation and new product
introduction.
Lead a team of manufacturing associates in a project to convert process documents to the new TQC
format.
Investigated and dispositioned nonconforming material. Worked with Supplier Quality Engineers to resolve
nonconforming issues with incoming and raw material.
Maintained manufacturing acceptance test failure database, in Microsoft Access, adding new input fields
and users.
Used Share Point to gather assembly issues and publish documents for new line.
Dako, Inc.
August December
Senior Technical Operations Technician
Member of technical operations staff supporting the production of medical devices: digital scanning
microscope, automated slide stainer and flow cytometers. Provided technical solutions for process related
issues and questions to keep production running smoothly.
Created and maintained revision controlled documentation in MS Power Point and Word, working with
Document Control in accordance with ISO standards. Worked with both R&D and Production to gather the
relevant information. Documentation included text with accompanying photos, drawings, screen captures
and solid models.
Edited documents to ensure their accuracy and completeness as well as working to improve the
documents structure and flow.
Member of collaborative team with Operations Manager and Quality Control Manager, creating formats for
process validation protocols and reports.
Developed process validation installation qualification, operational qualification and process qualification
protocols in Microsoft Word to meet FDA regulatory requirements from CFR part . Documented and
summarized results process validation. Gathered data from process validation in Microsoft Excel for
analysis.
Championed engineering change orders from creation to implementation in Agile product lifecycle
management database to resolve deviations, meet customer expectations and release new products.
Initiated, justified and implemented new equipment purchases for process implementation and new product
introduction.
Investigated and dispositioned nonconforming material.
Worked with Supplier Quality Engineers to resolve nonconforming issues with incoming and raw material.
Worked with service to create alerts and installation instructions, helping ensure engineering changes were
correctly implemented in field.
Volunteer for Nonprofit Corporation
March – June
Website Administrator
Setup and maintained website for nonprofit corporation.
Wrote HTML and CSS code for web pages and test across browser types.
Use Server Side Include to deliver common content across multiple pages.
Wrote Perl scripts to handle forms and deliver page content.
Created graphics for buttons and backgrounds.
Some javascript for animated buttons.
Volt Management Corp.
December April
Custom Systems Engineer
Contract position at Agilent Technologies, Inc. designing custom test system for Motorola wireless hand
held radios.
Generated engineering portion of proposals, in Microsoft Excel, estimating cost and time for engineering
functions.
Communicated with customer throughout design phase to ensure functional specifications were met.
Worked with the Software Engineer to establish parameters for system software.
Created presentation in MS Power Point to review system with Program Manager and customer for design
approval.
Used Visio to create illustrations for documentation.
Education
Bachelor of Science in Applied Physics
Colorado State University
Graduated May
Minor in Mathematics

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