Medical Engineering
Resume:
Perry W. Croll
**** *. ******* **** *****, Sandy, UT, 84092 Home: 801-***-**** Cell: 801-***-**** ******@*******.*** 1
Skilled medical device executive. Proven track record of design, development, manufacturing transfer, and market launch of critical care products, drug delivery systems, emergency medicine and surgical products.
Qualifications include: 19 years experience in medical device/pharma fields, mechanical engineering degree, and team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include, R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketing. Comprehensive knowledge of design for manufacturability, FDA QSR, MDD, and CMDR regulations. Listed as inventor or co-inventor on 8 US/international patents and 20 submissions. Expertise
Startups
Product R&D/Prototyping
Medical Device Design Engineering
Verification & Validation Testing
Cleanroom Manufacturing & Engineering
Injection Molding & Extrusion
Sterilization techniques and validations
FDA 510(k) generation and submission
International regulatory submission
CE Mark technical file generation and submission
Notified body ISO 13485 Quality Systems
Design Controls
SolidWorks
Packaging Design
Experience
31 Dec 2010, LMA International acquired WolfeTory Medical, Inc. The critical care portion of WolfeTory was spun-off as AbViser Medical LLC in Jan 2011. Concurrently worked at AbViser Medical and LMA International. Teleflex Medical acquired LMA International in Oct 2012. ConvaTec Inc. acquired AbViser Medical in May 2012. Teleflex Medical Inc., Anesthesia and Emergency Medicine Division, SLC, UT 2012-Present Teleflex acquired Wolfe Tory Medical Inc. (WTM) via acquisition of LMACO in 2012. LMACO acquired WTM in 2010. WTM remains a wholly owned subsidiary of Teleflex Medical. Director of R&D, 2014-Present – Reports to Division VP of R&D Responsible for Management of all R&D activities related to Strategic NPD and current branded product lines. Senior Director Operations, 2012-2014 – Reported to Division President Responsible for Plant Operations including R&D, Finance, Engineering, Manufacturing, & QAQC. Director of R&D Achievements
Designed and development novel prefillable unidose and multidose intra-nasal drug delivery system
Designed, developed, and launched line of high volume drug delivery systems with patent pending reuse prevention safety syringe, integrated dosing mechanism, and intra-nasal atomizer.
Selected, qualified and trained Chinese manufacturer to manufacture sterile multi-component device.
Designed and prototyped patent pending sealing device integrated to prefilled syringe.
Designed and prototyped patent pending ventilator induced pneumonia prevention device.
Completed integration of all Design History Files into Teleflex Agile electronic documentation system. Senior Director Operations Achievements
Successfully managed the reorganization and integration of Wolfe Tory Medical, post-acquisition, into Teleflex Medical’s Anesthesia and Respiratory Business Unit. This included elimination of Sales and Marketing and Regulatory Affairs; elimination of direct-to-customer sales to transfer of finished goods to Teleflex distribution; and adoption of Teleflex Quality Management System.
Increased average product margins from 78% to 82% during tenure.
Co-started direct-to-customer custom product OEM business unit within WTM which to date has sold over one million units worldwide. *Currently in discussions with Chinese and Indian customers forecasting volumes exceeding 50 million units by year 2017*.
Perry W. Croll
2063 E. Glacier View Drive, Sandy, UT, 84092 Home: 801-***-**** Cell: 801-***-**** ******@*******.*** 2
Wolfe Tory Medical (WTM) – SLC, UT 2000-2012
Startup manufacturer of emerging market medical devices for critical care medicine and topical drug delivery. LMACO acquired Wolfe Tory Medical Inc. in 2010. WTM remained a wholly owned subsidiary of LMA North America. VP Engineering & RAQA – 2010-2012 – Reported to Chief Operating Officer Manager Engineering &RAQA – 2000-2010 – Reported to Vice President Operations Engineering and R&D Responsibilities
Design and develop new products from concept, utilizing design software and prototyping methods, to commercialization in a cross-functional team atmosphere following current design control methods.
Initiate in collecting, developing, analyzing and revising customer requirements and design inputs.
Develop verification and validation protocols and reports on products, packaging and processes to assure specifications & regulations are met.
Communicate with doctors in clinical settings to meet requirements for future and current products.
Select and maintain relationships with component suppliers.
Provide technical expertise on materials, components, and manufacturing process.
Represent WTM in a Sales and Marketing capacity at industry tradeshows. RAQA Responsibilities
Direct and supervise quality inspectors on inspection techniques at IQA, in-process and FQA.
Prepare and conduct management reviews of the quality system and analyze results of audits, customer complaints, customer feedback, CAPA’s, NCMR’s, RMA’s, facility and human resources needs.
Manage internal and supplier auditing, CAPA’s, complaint handling, customer feedback, RMA, and nonconforming material reporting (NCMR) systems.
Generate and maintain design history files, device history records, device master records, technical files, and risk analysis documents compliant with FDA’s QSR and ISO13485.
Annually register to FDA and Canadian Medical Devices Bureau, device listings and establishment updates.
Represent the company during FDA, internal, supplier, customer and notified body audits.
Assist VP & Medical Director with development of FDA pre-market notifications, 510(k)’s.
Manage equipment and instrumentation calibration program.
Manage ISO Class 8 clean room annual certification and quarterly environmental monitoring program.
Oversee product sterilization assurance program. Achievements
Developed patent pending re-useable contamination free syringe system for single patient long-term use.
Design Patent D674892 for atomizing nozzle for nasal therapy.
Co-developed systems for detecting and monitoring intra-abdominal pressure in critically ill patients. Concept to market launch achieved in twelve months. United States Patent Numbers 7,112,177, 7,644,722, 7,726,328, 7,892,181 8,052,671.
Patented: Co-developed drug delivery atomization device that reduced manufacturing costs by 400% over old design. United States Patent Number 6,698,429.
Created ISO 13485:2003 Quality System. Passed NSAI Notified Body ISO registration audit first time.
Successfully passed 2002, 2007 and 2012 FDA audits with no 483’s assigned.
Launched ten proprietary products on schedule. Launched three contract manufacturing products on schedule.
Negotiated cost of components with suppliers to lower COGs and achieve business goals.
Completed regulatory registration globally of products which exponentially increased sales. Perry W. Croll
2063 E. Glacier View Drive, Sandy, UT, 84092 Home: 801-***-**** Cell: 801-***-**** ******@*******.*** 3
AbViser Medical LLC – SLC, UT 2011-2012
Startup manufacturer of Intra-abdominal pressure monitoring systems. ConvaTec acquired AbViser Medical LLC in 2012. Worked concurrently for WTM and AbViser Medical. WTM and AbViser Medical Responsibilities were the same. VP Engineering & RAQA – Reported to CEO
Achievements
Facilitated spinoff of AbViser Medical LLC from Wolfe Tory Medical.
Manned multiple tradeshows to demonstrate product and attract potential buyers.
Assisted with sale to ConvaTec.
Olive Medical Inc. – SLC, UT 2009-2014
Startup manufacturer of Intra-abdominal pressure monitoring systems. Johnson & Johnson Mitek Sports Division acquired Olive Medical February 2015. Engineering & RAQA Advisor
Responsibilities
Provided startup phase Engineering and RAQA guidance for minimally invasive surgical visualization products and technologies.
Achievements
Mentored team to develop ISO 13485 complaint quality system which passed first notified body audit.
Granted CE Mark for submitted technical file.
Patent pending viewing trocar with integrated prism for use with angled endoscope.
Assisted with design of disposable endoscope.
C.R. Bard Corporation – SLC, UT 1999-2000
Quality Engineer
Responsibilities
Manufacturing consolidation and transfer of silicone and polyurethane catheters, ports and associated engineering documentation. Vascular access devices were transferred from Salt Lake City, UT to Reynosa, Mexico and from San Antonio, TX to Reynosa, Mexico.
Develop design verification and validation protocols and reports.
Supervise R&D engineering technicians for physical testing of product related to verification and validation. Achievements
Prevented potential recall on catheter line, by discovering guide wire hydrophilic polyurethane coating in the fluid path of the catheter lumen, determined cause, and rectified non-conformance. Theratech Inc. – SLC, UT 1997-1999
Startup pharmaceutical manufacturer of transdermal drug delivery patches. Theratech was acquired by Watson Pharmaceuticals in 1999.
Process & Validation Engineer
Responsibilities
Develop IQ, OQ, and PQ’s for manufacturing and facility equipment validation.
Process development and scale-up of transdermal products from R&D into manufacturing.
Train engineering technicians and production equipment operators on use of new equipment, processes, quality procedures and system diagnostics.
Achievements
Developed specifications for $2 million high-speed transdermal fabrication and packaging machine.
Created and implemented IQ/OQ/PQ validation protocols and reports for fabrication, packaging, and facility equipment to successfully scale-up and launch anti-wrinkle patch available in most major drug stores.
Selected to supervise 25 production employees on weekends as needed to meet and exceed delivery date goals.
Perry W. Croll
2063 E. Glacier View Drive, Sandy, UT, 84092 Home: 801-***-**** Cell: 801-***-**** ******@*******.*** 4
National Assessment Institute – SLC, UT (company closed) 1996-1997 National engineering, healthcare and trade licensing test development company. Mechanical Engineer
Responsibilities
Developed licensing examinations for professional engineering, fundamentals engineering and mechanical/electrical trades.
Achievements
Presented training seminars nationally to subject matter experts in mechanical and electrical trade professions to gather, assimilate and organize information relative to ongoing exam development and latest methods and technologies.
Kinetic Systems, Inc. – Lehi, UT (Micron Plant Closed) 1995-1996 Installed UHP gas piping for $450 million DRAM chip manufacturing facility. Quality Engineer
Responsibilities
Training, development of QAQC procedure manuals, inspection of UHP welded stainless lines. Achievements
Enforced QAQC protocols for the installation of high purity gas/water distribution systems.
Qualified local union welders in orbital welding techniques of EP316L stainless steel piping, which resulted in utilization of local skilled workers and regional cost effective wages. Crowley Maritime Corporation – San Francisco, CA 1990-1994
$2 billion dollar marine transportation company
Senior Port Engineer
Responsibilities
Management of $150 million of marine engineering equipment; responsible for repair, retrofit, new build and dry-docking of ocean going vessels, including propulsion. Achievements
Selected for Port Engineer Management Trainee Program. Included one year training rotation at field office sites in Alaska, Washington, Florida, Puerto Rico, and California.
Managed 60 employees and material resources to effectively direct the maintenance and repair of equipment including medium speed diesel engines, power generation and distribution, pneumatic controls, HVAC, hydraulic systems, and vessel structure.
Managed the repair of a cargo ship underway at sea. Saved $1 million dollars by preventing dry dock expenses and delay of cargo shipment.
Assisted with onsite “post cold war” relocation of a U.S. Navy nuclear submarine flotilla from Scotland to Italy.
Education
University of Utah – Salt Lake City, UT 1995
Anatomy and Physiology Concentration 4.0 GPA
EMEDCO – Murray, UT 1997
EMT-B, Emergency Medical Technician - Basic
CSU, California Maritime Academy – Vallejo, CA 1986-1990
BS Mechanical Engineering
4 year Varsity Crew Team Athlete
Awarded Highest GPA, Scholar Athlete
Midshipmen Executive Officer, 3E Engineering Division, 1990 Perry W. Croll
2063 E. Glacier View Drive, Sandy, UT, 84092 Home: 801-***-**** Cell: 801-***-**** ******@*******.*** 5
Volunteer Experience
Emergency Medical Technician, 4th Street Homeless Clinic, SLC, UT
Emergency Medical Technician, Mount Timpanogos Emergency Response Team Hobbies
Travel. Traveled to 29 countries and 46 states.
Running and cycling. Completed 30 ultra-marathons/marathons and 3 cycling centuries.
Reading and research.
Skiing, hiking, and camping.
Patents/Publications:
8 US patents issued, 20 US Applications filed, Feb 23, 2016 most recent Patent Grant Patents/ Publication # Title
9,265,898 Applicator for oro-pharyngeal anesthetic 8,052,671 Intra-abdominal pressure monitoring device and method 7,892,181 Apparatus for monitoring intra-abdominal pressure 7,726,328 Medical valve and method to monitor intra-abdominal pressure 7,644,722 Medical valve and method to monitor intra-abdominal pressure 7,112,177 Apparatus for monitoring intra-abdominal pressure 6,698,429 Medical atomizer
D674892 Atomizing nozzle for nasal therapy
2015/0038,904 Auto-disable syringe assembly
2014/0275,771 Viewing Trocar with integrated prism for use with angled endoscope 2014/0088,455 Apparatus for monitoring intra-abdominal pressure 2013/0298,902 Atomizer for nasal therapy
2013/0277,443 Miniature fluid atomizer
2012/0289,896 Percutaneously deployed abdominal drain 2010/0094,173 Pressure control for catheter drain tubing 2010/0087,852 Temporary surgical closure for a body cavity 2010/0065,062 Temporary pharyngeal airway
2009/0314,973 Medical valve and method to monitor intra-abdominal pressure 2008/0114,316 Intra-Abdominal Pressure Monitoring Device and Method 2008/0103,408 Continuous Intra-Abdominal Pressure Monitoring Urinary Catheter W/Optional Core Temp. Sensor 2007/0255,167 Apparatus for monitoring intra-abdominal pressure 2007/0106,226 Syringe with internal sleeve
2007/0038,143 Medical valve and method to monitor intra-abdominal pressure 2006/0058,702 Apparatus for monitoring intra-abdominal pressure 2004/0215,155 Wound irrigator
2004/0176,703 Apparatus for monitoring intra-abdominal pressure
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