Manager Project
Resume:
Michael C. Heath
Chelmsford, MA 01824
978-***-**** (C)
978-***-**** (H)
***************@*******.***
Summary
Results oriented Program Manager with over 10 years experience developing,
and launching products in the medical, and life sciences markets. Proven
leadership, problem solving and organizational skills, this can enhance
your company's ability to deliver products in a timely fashion. Proven
record leading technical programs, managing budgets, reducing development
cycles, transferring products from R&D to market.
. Develop and launch products
1. Program Management
2. Customer Management
3. Troubleshooting & on time implementation
4. Change agent
5. Lean Manufacturing & Six Sigma
Professional Experience
Teleflex Medical OEM, Mansfield, MA
2007- Present
Medical device manufacturer of catheters, introducers, dilators, sutures,
surgical instruments and implants.
Program Manager, OEM Specialties
. Project planning, budgeting, lead process development, and scale up of
disposable devices.
. Account management responsibility of OEM partners
. Managing transfer of cardiac valve repair components. $2.1MM planned
FY'10
. Led two vascular closure product integrations. $4.2MM revenue
. Managed integration and validation of manufacturing expansion project.
$1.6MM new business FY'09
. Managed implementation of urology catheter product line. $690k new
business FY'09
. Led scoping initiative for pain management introducer and catheter
BD Biosciences, Billerica, MA
2003- 2007
Global medical technology company serving medical, life sciences, and
clinical diagnostics industry
Innovator of science products the discovery and development of new drugs,
vaccines, and the diagnosis of diseases.
Program Manager, R/D&E
. Project planning, process development, and scale up of cancer detection
device. $1MM in new revenue FY'06
. Managed integration and validation of OEM sourced cell assay product
line, sustaining $7MM annual revenue
. Led process scale up and transfer of high automation product line to
ensure dual source capability.$2MM
. Managed integration and validation of serum binding assay product. $600k
annual revenue
Aspect Medical Systems, Newton, MA
2001-2003
Innovator and manufacturer of products which monitor the effects of
anesthetics and sedatives on the brain
Lead Development Project Manager
. Project planning, development cycles and testing from inception to
manufacturing release of disposable sensors.
. Co developed semi reusable device for the international market. $6MM in
new revenue realized
. Secured alternative source materials for key product line. $220k in cost
savings
. Assisted in exploration of BIS technology for Neuro diagnostics for such
diseases as Alzheimer's and depression.
Pall Filtron Corporation, Northborough, MA, Div. of Pall Corporation
Manufacturer of ultra filtration membranes and systems in the
pharmaceutical, laboratory and biotech markets.
Development Manager- R&D Department
1998-2001
. Provide project planning, budgeting technical leadership for of
innovative ultra filtration products
. Search and qualify outside vendors related to materials, equipment and
new technologies
. Responsible for department and capital budgeting; administration of staff
of five technical personnel
. Led development, manufacture and market launch of bench top UL approved-
instrumentation system. $1.5MM revenue.
. Led documentation conversion to Vaulted Cad system
. Transferred manufacturing and R&D sites during plant closure
Technical leader of product scale up of high volume automation. $600K
cost saving.
Page 2
Michael C. Heath
Manufacturing Engineer-
1996-1998
. Hands on development and scaled up two plastic disposable devices to high
automation. $350k of new business.
. Managed capital projects in excess of $900k between engineering and
manufacturing
. Led installation and qualification of clean room operation for laboratory
device line.
Millipore Corporation, Bedford, MA
Manufacturer of separation and purification products to pharmaceutical,
laboratory, and life science
Global Product Coordinator - Bio-Process Division
1995-1996
. Led qualification activities of multi-site sourcing program to ensure
product consistency through continuous improvement.
. Performed audits for products and processes manufactured to ensure
changes do not impact worldwide consistency
. 35% of customer base converted to multi source program -- $1.5MM annual
cost savings planned
Advanced Engineering Liaison - Analytical Division
1993-1995
Led 510k activities and implementation of high flow membrane /device.
$800k in new business.
Oversaw conversion and qualification of disposable medical device to Gamma
compatibility.
Led and implemented materials / mold technology conversion to product line.
$400k cost savings.
Led qualification and product launch of new OEM lab / tissue culture
filter. $300k/yr in new business
R&D Program Manager - Lab and Healthcare Group
1991-1993
. Responsible for product development of disposable medical device from
concept through manufacturing.
. Project planning, budgeting and leadership of cross-matrixes team.
. Liaison to strategic partner; responsible for reporting to management and
partner.
Led development team to launch new product which resulted in $2MM in new
business.
Led product design reviews to define product specifications and ensure
compatibility of product and market criteria
Coordinated clinical trials in conjunction with strategic partner to
support 510k filing.
Senior Product Development Engineer -Lab and Healthcare Group
1988-1991
. Technical interface to OEM partners.
Led material studies and implementation of disposable lab device to gamma
radiation compatibility. $1MM in new business.
Coordinated re-engineering and qualification of IV filter from EtO
sterilization to radiation--sustain $ 4MM product line.
Education and Professional Development
BS Plastics Engineering, University of Massachusetts, Lowell, MA
Business related courses
Company Sponsored Training:
. Project Management
. Lean and Six Sigma Training
. Team Dynamics & Effectiveness
. Negotiation and Conflict Management
. Operating room training
. Quality auditing
. SAP
. Business Ethics
Achievements
Patent 7404873 Substrate Membrane Attachment Process
Patent 5439587 Disposable Self Priming Medical Filter Device
Professional Affiliations
SPE Society of Plastics Engineer
PMI Project Management Institute
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