Project Manager Management

PROJECT MANAGER

Accomplished in leading, managing and supporting cross functional teams to

meet project goals and objectives. Experience with engineering design,

product development, manufacturing operations and business processes

requiring medical device Quality System compliance. Management and

leadership skills developed from functioning as a department head, working

with adult volunteers in a youth program and as project manager in matrix

managed environments. Accustomed to taking intelligent risks with

incomplete or imperfect information. Background in mechanical design,

technical writing and all facets of change control/data management.

SKILLSET PROFICIENCIES

. Project Management Methodologies . Quality Systems Compliance .

Team Leadership

. Product Development Lifecycle . Process Improvement . Budget

Management

. Engineering Design . Change Management . MS Office Tools

. Data Management . Manufacturing Processes . Mechanical Design

. Lean Six Sigma . Technical Writing

SELECT ACCOMPLISHMENTS

Consulting 2009-present

. Created Gap assessments on IQ/OQ/PQ validation reports and initiated

FMECA's on manufacturing processes for remediation and Quality System

compliance. Coordinated the review and presentation to the customer for

additional inputs and disposition.

. Refined change and data management protocols to reduce cost and time

required to process changes to engineering and manufacturing documents

for a firm involved in stem cell therapy.

Project Manager - Avail Medical Products 2006-2009

Contract Manufacturer of Disposable Medical Products

. Coordinated the transfer of manufacturing clean room operations,

equipment and processes for product lines moving 90 miles. Accomplished

with no delay to delivery commitments for $3M of product to multiple

customers. Held daily status (SCRUM like) sessions with manufacturing,

quality and other team members to assure a smooth transfer in

requalifying and validating equipment and developing processes that

lacked the 'tribal knowledge' missing from the legacy documents. Ensured

extensive training for the receiving production management, operators and

technicians as they were unfamiliar with the equipment or the product

lines.

. Lead a team in introducing, training and deploying a manufacturing

execution system (MES) to improve quality, reduce costs and provide data

for continuous improvement analysis. Plans were to phase this on to over

50 production lines in 9 factories. Significant input came from Equipment

Engineering, Facilities, IT, and Plant management as well as the

Engineering; Manufacturing and Quality organizations.

. Drove a rapid deployment team in a 12 week effort to build and deliver a

dormant product to meet a customer commitment. Annual revenues estimated

at $300,000. Extreme efforts were coordinated and delivered in re-

qualifying tooling and processes, acquiring raw materials, training

technicians, building and shipping product.

Project Manager - Nichols Institute Diagnostics 2004-2005

Medical Laboratory Assays and Equipment

. Coordinated activities and facilitated weekly meetings among mechanical,

electrical and software systems engineers in the U.S. and Australia on a

$5M project to develop an automated diagnostic analyzer.

. Promoted consultations with the scientists and chemists developing assays

to be used on the instrument to assure design integrity, DFM and minimize

scope creep.

Project Manager - Pulse Engineering 2001-2004

Electronic Components

. Facilitated the design, quality, manufacturing and supply chain efforts

for the Excelsus product line between US design and China production

facilities to transfer multiple new products into manufacturing. First

year revenue estimated at $5M.

. Managed the development lifecycles for multiple projects. Executed and

updated project schedules, milestones, scope of work definitions,

material cost, lead time analysis and follow-up on each.

. Moderated local and international project meetings with inputs from all

functions in the company. Outputs were weekly reports and punch-lists

used as agendas for subsequent meetings.

Document Control / CAD Manager - Excelsus Technologies 2000-2001

Document Control/CAD Manger with Excelsus (prior to the acquisition by

Pulse)

. Assumed management of the CAD group for a rapidly growing startup.

. Created the procedures and established controls to record engineering

design, manage changes and formalize design reviews to position the

company for managed growth.

. Wrote the requirements and coordinated the evaluation of a Product Data

Management (PDM) software.

Technical Writing Consulting - Self Employed 1999

Contracted with regulatory experts to provide basic procedures in

engineering design control, document control, quality inspections,

purchasing, and receiving, for small and start-up organizations needing

to be 21CFR820 compliant.

Engineering Manager - ThermoScan / Braun 1995-1999

Consumer and Professional Medical Products

. Managed the machine shop, CAD and document control groups supporting new

product development, sustaining engineering and off-shore manufacturing.

. Reduced cost and processing time of engineering changes 75% by re-

aligning department personnel, enforcing baseline procedures for design

reviews and creating and mediating change review boards.

. Devised an electronic/computer managed ECO system without writing code by

creating tables and manipulating the read/write controls for files and

folders.

. Contributing member on the team to align policy, procedures and processes

with Quality System guidelines for ISO certification.

Mechanical design and engineering experiences were before 1995

PERSONAL ACCOMPLISHMENTS and OUTSIDE INTERESTS

Eagle Scout

Boy Scout Leader 1994-2001

professional ASSOCIATIONS

Association of Configuration and Data Management (ACDM), Board of

Governors, 1997-2002

EDUCATION

Bachelor of Science; Industrial Education; Rhode Island College,

Providence, Rhode Island

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