Bruce Allen Church
New Brighton, Minnesota 55112
Overview
A results oriented, creative problem solver dedicated to continuous
improvement, I have contributed to product development as quality
assurance, manufacturing and design engineers as well as Program Manager,
PD Engineering Manager, Directors of both Product Development and
Manufacturing in startups at large and small companies.
Skills/Capabilities
( Effectively interface with physicians/customers to
establish/clarify product needs
( Create a MS project plan to quickly bring new ideas to market with
high quality
( Earned a reputation for hiring good people
( Manage, mentor and develop people
( Lead cross-functional efforts to successfully commercialize new or
improved products
( Interface effectively with assemblers/operators to develop and
train on new processes
( Identify and lead continuous improvement activities
Professional Experience
( Contract Engineer Neometrics Inc, Plymouth Minnesota 1/09-8/09
( Developed a non-contact soldering technology for multiple
materials used in vascular guidewires
( Director of R&D, Cardiovascular Systems, New Brighton Minnesota, 4/05-
1/09
. Worked with clinical study physicians to identify product improvements
. Supported the submission of the companies first 510k
. Developed next generation devices that improved clinical efficiency
. Developed special guidewires and ancillary products for these devices
. Hired staff to support this growing company
( Led projects to bring in new accessory products
( Director of Product Development, Enova Medical Inc., 6/99-1/05
. Developed and launched a 2.7 Fr Quadripolar Neuro-stimulation Lead
. Developed and launched the worlds first cordless surgical headlamp
. Developed and installed new processes for client companies
. Frequently interfaced with auditors from client companies, FDA and ISO
notified bodies
( Certified as a compliance auditor by Alquest Inc.
( President, Havahome Inc., 8/97-5/01
( Bought, rehabilitated and resold residential housing
( Director of Manufacturing, SciMed Life Systems, Maple Grove
Minnesota, 5/93-6/97
. Led the operations side of an internal startup to develop and
manufacture SciMed's first high-volume, low cost product
( Hired the staff and established the manufacturing strategies in
this successful effort
( Lead the development team through the final pre and post launch
activities
( Launched at 350% of forecast
( Achieved 25% US market share at 50% gross margin in less than 2
years
( Process Development Manager, SciMed Life Systems, Maple Grove
Minnesota, 5/90-5/93
( Developed this group to partner status with R&D
( Eliminated new product back orders with early operations
involvement
( Created a pilot lab coordinator position dedicated to a each new
device
( Used production personnel in development, managed by the pilot lab
coordinator, who then became to core of the new line in production
( Program Manager, Medtronic Inc., Fridley Minnesota, 3/89-5/90
. Brought 15 cardiac pacing lead models to market in 15 month
( Senior R&D Engineer, Medtronic Inc., 5/84-2/89
( Designed new pacing leads that transferred to Puerto Rico with
record yields
. Taught a Pacing Lead Technology course to practicing physicians
( Led the creation of Medtronic's first polyurethane lead design
and process standard
( QA Engineer, Medtronic Inc., 5/77-5/84
. Qualified new processes and products in both pulse generators
and cardiac pacing leads
. Qualified products transferred between plants
. Developed a new self-monitoring cleaning process for pacemaker
internals
. Identified a new product design issue that prevented a recall
Education: B.S. in Chem. Eng. from the University of Minnesota's Institute
of Technology
References
Susan Trahan, Director of Research and Development, Neometrics Inc.
763-***-**** x119
Paul Robinson, Vice President of Operations, Sterling Critical
Products 612-***-****
Larry Walter, Sr. Process Development Engineer, Innovize Inc.