MS Series: CX, CXR, and LGX. Also, wrote design verification protocols for the AMS 800 Series (Urinary Control System). Shelf Life Studies - Evaluated accelerated aging studies for the AMS 700 series. Test Method Validations (TMVs) - Designed and managed TMVs utilizing gage R&R studies and analyzing via Minitab for the AMS 700 series and Ambicor (Two-Piece Inflatable Penile Prosthesis) products; problem solved on difficult TMVs requiring the use of surrogate materials. Process Validations: Designed and prepared protocols/reports for the AMS 700 MS Series and the AMS 800 series. Equipment Qualification - Qualified manufacturing equipment for the AMS 700 MS Series. Boston Scientific, Inc. Maple Grove, MN Sr. Design Assurance Engineer/Process Development Engineer Oct 2006 - Nov 2013 Catheters - Responsible for the Rotablator Atherectomy device, non-vascular interventional drainage catheters - (C-Flex, Flexima, and Percuflex), OMEGA stent delivery system catheter, NC Quantum Apex PTCA dilatation catheter, Apex PTCA dilatation Catheter while working in Sustaining Engineering AccuStick Introducer System with RO Marker - Responsible for the quality documents of the AccuStick Introducer System. This device was reversed engineered to be manufactured at a BSC site. Developed the design verification testing. Quality - Followed company Corporate SOPs, ISO 47971, ISO 13485, GMP (Good Manufacturing Practices), QSR (Quality System Regulation), and FDA Guidance Documents. Quality documents - Responsible for the following documents: NCEP, CAPA, PIR, FMEA, Risk Management Plan/Report, Hazard Analysis, and Field Assessment Plans/Reports Testing: Worked with IQs, OQs, PQs, DOEs, Design Verification testing, and Design Validation testing. Test method development - Developed two test methods for vacuum testing of drainage catheters. Testing - Coordinated design verification shelf life testing of over 1,000 non-vascular drainage catheters at 4 different sites to perform against 17 different test methods. Pilot Lab - Set up a pilot lab for the early development of a DES SFA (drug eluting stent for the superficial femoral artery). Involved in the early catheter development of this device while working in Process Development. The device later became known as the Innova Over-The-Wire self-expanding stent system. St. Jude Medical, Inc. Minnetonka, MN Product Development Engineer 2001 - 2006 Vascular Closure Device - Designed and developed a collagen folding pattern for the AngioSeal VIP. Developed different testing methods to test the sealing capability of the design. Received a patent for a locking nut design. Xoft microTube, Inc. Plymouth, MN R & D Engineer 2000 - 2001 Catheter - Designed, developed, and tested a complex multi-lumen catheter for the delivery and cooling of a miniaturized x-ray tube for brachytherapy treatment. Colorado MEDtech Catheters and Disposables Technology, Inc./ Novel Biomedical, Inc. Plymouth, MN R & D Project Manager 1998 - 1999 Catheters - Involved in the technical development of anesthetic drug delivery catheters, balloon catheters, intra-coronary radiation therapy catheters, RF ablation catheters, and hemodialysis catheters. MediCon, Inc. Eden Prairie, MN Engineering/QA 1997 - 1998 Metal alloy implants - Developed the manufacturing process for a metal alloy implant to be used in conjunction with electro-magnetic radiation therapy for treating BPH. Browne Medical Systems, Inc. White Bear Lake, MN R & D Project Manager 1996 Urethral inserts - Presented a daily use urethral insert concept for the treatment of female stress urinaryincontinence. The product went from concept to human clinical trials in Canada in nine months. Received a Patent for the daily use device. Iotek, Inc. Minneapolis, MN R & D Engineer 1995 Urethral inserts - Designed, developed, and tested several urethral insert concepts for remove-to-void devices in the treatment of female stress urinary incontinence. Attended and evaluated the human clinical trials. NURSING EXPERIENCE Minneapolis Medical Research Foundation Minneapolis, MN RESEARCH NURSE - drug studies Abbott-Northwestern Hospital Minneapolis, MN REGISTERED NURSE - urology & gastrointestinal, post PTCA United States Army Hospital Wuerzburg, Germany REGISTERED NURSE - general medical/surgical
