Cumming, GA 30041 Phone (678) 468-6301

E-mail Gesobus@aol.com

Gary Sobus

Summary of Over 25 years of successful, goal oriented strategic managerial experience in Engineering, Quality
qualifications Management, Quality Assurance, Compliance, Validation, Operations and R&D Management with
specific experience in manufacturing engineering and operations for medical devices and
combination products.
Energetic, output oriented, Engineering Director with progressive experience in diversified
manufacturing environment with a unique combination of project management and leadership
experience.
Technical skills include; injection molding and extrusion of plastics, metal stamping, metal forming,
Die casting, welding and machining of metal and plastic components.
Experienced with manufacturing both disposable and durable products including packaging and
sterilization efforts.
Proven ability to deliver innovative solutions that fully supports corporate growth objectives.
Multiple experiences in start-up of new operations, Design Control Management, Verification and
Validation, fiscal planning and management, work simplification, lean manufacturing, DMAIC Six
Sigma, workplace automation and process improvement.
Strong knowledge of quality control, quality assurance, design controls, 510(k) submissions,
Internal and External quality auditing, corrective and preventative action process, change control
practices, Change Control Management and DOE.

Work May 2010 to Present CHART Industries, Ball Ground, GA

experience Director, Innovation and Sustaining Engineering
Led initiative to strengthen and grow the Biomedical Research and Development, Innovation,
Sustaining and Manufacturing Engineering teams and to provide leadership, strategic direction,
and management for the engineering functions within the Biomedical Division.
Responsible for seeking out new potential business to grow the respiratory and cryogenic
storage business within the Biomedical Division.
Team leader for new product development projects requiring oversight to ensure products under
development follow full design controls and the Global Product Commercialization Process.
Product launches include; Strategic resourcing of critical components to address quality and
performance issues, 510(k) submissions, new design and release of a cryogenic freezers, new
freezer controller, Stationary oxygen concentrator and cryogenic specimen storage Dewar.
Provided team direction and leadership for creating and implementing a new quality
management and design controls process.
Provided team direction and leadership to bring the current product lines in compliance to the
rd
new 60601 3 edition requirements.
Provide team direction and responsibility for overseeing timely patent filing protection,
confidentiality and design agreements.
Provide technical leadership to the engineering team for complying with the RoHS2 initiatives.
Responsible for directing the manufacturing engineering functions including manufacturing
methods, engineering standards, product validations including IQ/OQ/PQ activities, plant
engineering efforts such as FMEA and PFMEA, Design Controls, equipment selection and design,
Lean practices and process validation efforts.

June 2008 to May 2010 KCI, San Antonio, Texas

Director, Research and Development 2008-2010 TSS R&D
 Led initiative to strengthen and grow the Therapeutic Support Research and Development team
and to provide strategic direction and management for a group consisting of 8 associates, 3
consultants and 3 key strategic business partners.
Team leader for new product development projects requiring oversight to ensure products under
development follow full design controls and the Stage Gate Approach to Project Management
Responsibility for product five product launches with new surfaces and beds.
Provide technical engineering management and leadership within the Therapeutic Support
Systems, sustaining engineering group to provide dedicated leadership in support of growing the
TSS business.
Responsible for directing the manufacturing engineering functions including manufacturing
methods, engineering standards, product validations including IQ/OQ/PQ activities, plant
engineering efforts such as FMEA and PFMEA, Design Controls, equipment selection and design,
Lean practices and process validation efforts.
Established team to address internal audit findings and outstanding CAPA actions.
Direct Franchise Readiness Assessments for domestic US and Canada products requiring UL
60601 update due to UL withdrawal of the UL544 standard.

1997 to June 2008 Covidien, formerly Tyco Healthcare

Engineering Manager 2004-2008 Puritan Bennett Plainfield, Indiana
Transferred to Puritan Bennett to provide technical engineering management and leadership within
the oxygen therapy group undergoing a management transformation from groups to a more
traditional staff.
Responsible for directing the Plainfield Plant manufacturing engineering functions including
manufacturing methods, engineering standards, product validations including IQ/OQ/PQ activities,
plant engineering efforts such as FMEA and PFMEA, equipment selection and design and process
validation efforts.
Lead the efforts as the sites project manager for a facility expansion project costing in excess of
$3M.
Oversaw the machine center manufacturing operations for six months as part of a cross training
self-development initiative. Reduced the machine center cost from over $55/hr. to under $48/hr.
Responsible for overseeing the efforts to incorporate cost saving projects that increase the bottom
line by $1.3 million in 2005, $500k in 2006 and $1.4 million in 2007.
Lead the manufacturing engineering efforts to bring four new products to market.
Managed the validation engineering functions to assure compliance with corporate programs and
FDA/ISO, DOT, TPED, Canadian, Japanese and Swiss requirements.
Provide oversight to the plant engineering operation (facilities), which includes supervision of all
environmental and regulatory issues such as wastewater discharges, air permits and rainwater
runoff.
Engineering Manager 2002-2004 Kendall Healthcare Argyle, New York
Transferred to Kendall Argyle to provide technical engineering management and leadership at two
manufacturing sites supporting the Dialysis-Vascular and Critical Care business units.
Supervise and review the establishment of all engineering production standards for labor, scrap,
set-up and bills of materials.
Responsible for the cost savings and cost avoidance initiatives for both Tyco Healthcare plants in
Argyle, New York.
Optimized automated equipment through redesign of mechanical stations and reprogramming of
the PLC logic, which improved productivity from 43% to 97% efficiency.
Implemented a scrap tracking procedure to aid the engineering and production groups with
identifying cost savings/cost avoidance opportunities that has yielded a monthly savings of $15,000
material variance.
Completed a make versus buy project including a material change that involved biocompatibility
study and testing yielding an annual savings of $265,000.
Provide oversight to the plant engineering operation (facilities), which includes supervision of all
environmental and regulatory issues.
 Engineering Manager 2000-2002 U. S. Surgical Fort Worth, Texas
Responsibilities include designing, qualifying and implementing design modifications to improve the
overall performance of the products.
Redesigned and Qualified “Tacker Hernia Repair Fastener” from multi-part design to single
component design generating an annual cost savings of $1M.
Redesigned “Blunt Tip Trocar” to reduce scrap, generated during testing, from 45% to less than 4%
without negatively affecting use or effectiveness of product.
Experience with wire drawing, progressive die stamping, MIM, and 3-axis machining centers for
manufacture of “Skin Staplers” and staples.
Evaluated manufacturing lines/cells which improved productivity, improved quality and reduced
scrap/rework by 25%
Generated cost saving projects that produced an annual savings of $909,000.
Instrumental with automating several areas of the manufacturing process to improve the
manufacturing efficiency and cost savings through the use of LEAN practices.
Senior Divisional Engineer 1999-2000 U. S. Surgical North Haven, Ct.
Engineering responsibility for overseeing all engineering functions of transferring products acquired
through mergers to the US Surgical Fort Worth facility.
Senior Manufacturing Engineer 1997-1999 U. S. Surgical North Haven, Ct.
Instrumental with process changes that resulted in increasing the efficiency of an automated
assembly process from 69% to 90% daily average.
Continuous improvement focused on scrap reduction and equipment utilization

Senior Systems Engineer, General Dynamics 1996-1997

Cognizant Engineer for the design of and development of system for the new attack submarine
program.
Senior Shift Test Engineer, General Dynamics 1988-1997
Acted as Electric Boat’s on-the scene representative to ensure the proper conduct of testing
nuclear reactors and related systems onboard new construction and commissioned ships.

Education/ Bachelor of Science Technology in Mechanical Engineering:

Training Rochester Institute of Technology, Rochester, NY
ISO 13485
ISO 9000
Pro Engineering (Pro E), AutoCAD and Solid Works
Kepner Tregoe Project Management
Validation Training
Lessons in Leadership Program and Diversity Training
Advanced Excel for Window
Geometric Dimensioning and Tolerancing
Blood borne Pathogens Training
Supervisory Skills Training
Naval Nuclear Propulsion Radiological Controls Training
NAVSEA 08 Naval Nuclear Propulsion Training/Certification
Guiding Conflict Resolution and Positive Human Resource Practices
Failure Investigation
DMAIC Six Sigma Green Belt (trained)
OSHA 10-hour safety training
UL/IEC/EN 60601 training
RoHS and RoHS2