Engineer Medical Device
Resume:
Karl R. Leinsing, MSME, PE
Hampton, NH 03842
603-***-**** tel / 603-***-**** fax
603-***-**** cell
*********@************.***
CAREER SUMMARY:
Medical device and automation experience since 1986. Areas of expertise include full life cycle
product development of medical devices in the field of intravenous (IV) drug delivery, needle-free
valves, endometrial ablation, medical textiles, hernia repair, stent fixation, and mitral valve repair
(minimally invasive & percutaneous approaches). Currently hold 19 patents (others pending), 5
design awards, designs published by Life Magazine, and was recognized as one of 100 notable
people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI)
publication in June 2008.
EDUCATION:
May 1995 M.S. in Mechanical Engineering, NC A&T State University, 3.9/4.0 GPA
June 1992 Professional Engineering Licenses, NC: 18508 and NH: 11437
May 1988 B.S. in Mechanical Engineering, UNH, 3.4/4.0 Major, High Honors
EXPERIENCE:
2/06-Present ATech Designs, Inc. President
Medical device product development and consulting since 1998
Cardiovascular, surgical, intravenous, endoluminal, percutaneous devices
Invented and developed Programmable Electrode Array Knitter (6,158,250)
RF endometrial ablation via conductive knitted mesh to cure menorrhagia
Development of medical textiles
Invented & developed minimally invasive mitral valve repair device (8,092,363)
Expert witness for patent & liability cases (plaintiff & defendant) with testing,
epoxy-filled cross-sections of parts, SEM failure analysis, CT scans, report
writing, demonstratives, deposition, & trial experience.
Visit www.atechdesigns.com for more information
3/05-2/06 Mitralign, Inc. Director of Biomedical Engineering
Developed implants required for percutaneous mitral valve repair (pat. pending)
Successfully invented & developed new anchor within 2 months of hire
Completed locker implant used to plicate the anchors and lock sutures
Completed all implant goals and 10 animal studies within 6 months
6/02-2/05 ONUX Medical, Inc. - Manager of Design Engineering
Invented, developed, and tested a needlescopic Nitinol fixation device for
abdominal aortic aneurysm (AAA) repair in 10 months (patent pending)
Performed animal studies and trained surgeons on use of device
Designed a disposable laparoscopic Q-ring fixation device below cost targets -
[Designed in quality by designing for manufacturing and assembly]
Design history files were ISO compliant and most organized in the company
10/92-4/02 ALARIS Medical Systems (formerly IVAC & imed) - Sr. Principal Design Engineer
(Director Level Engineer).
Designed and qualified medical IV drug infusion products using FDA Quality
System Regulations and ISO 9001 procedures
Extensive knowledge of polymer selection, high volume production, IV
therapy, chemical resistance, fracture mechanics, measurement equipment,
design-of-experiments & EtO/Gamma/E-beam sterilization
Researched and selected injection, compression, injection-compression,
transfer, flashless, liquid injection molding (LIM), gum injection, vertical, and
rotary molding methods by working closely with molding suppliers
Designed plastic parts, ultrasonic welding fixtures and processes,
DecoupledSM Molding processes, high speed leak and flow testing systems,
UV adhesive and solvent joints, and automation
Promoted five times from Product Engineer II to Sr. Principal Design Engineer
Managed projects throughout product life cycle that included conception,
design, manufacturing, high volume production, and release to the customer
Sole inventor of the $300 million SmartSite Needle-Free Valve that leads the
sales of IV pumps and disposables (this project has been identified as the most
successful project in the history of the company)
Inventor of 8 patents for the SmartSite Needle-Free Valve (5,549,577 /
5,676,346 / 5,839,715 / 6,142,446 / D468016 / 6,706,022 / 6,802,490 /
6,875,205 / 6,971,630 / 7,104,520 / 7,125,396 / 7,184,825 / 7,244,249 /
7,306,199 / 7,497,848 / 8,029,472 / 8,177,768)
Winner of 5 awards for the SmartSite Valve - 1998 Medical Design Excellence
Award (MDEA), 1999 NC Governors New Product Award, 2000 NSPE New
Product Award, 2001 Prototype Design Award, and 2003 MDEA Gold Winner
SDRC Master Series 8.0, MARC, AutoCAD 14, and MoldFlow were used for
solid modeling, finite element analysis, drafting, and mold filling analysis
3/90-10/92 Draper Corporation - Mechanical Design Engineer.
Designed textile loom & knitting machines (achieved 600 rpm speed goal!)
Used knowledge of tribology, cams, gears, bearings, servo motors and controls,
electromagnetics, pneumatics, PLC's, PC oscilloscopes, and sensors
Deflection and stress analysis using own finite element programs
Electromagnetic analysis using MSC/XL-EMAS finite element program
6/88-3/90 Harris Graphics Corp. - Design Engineer - W eb offset printing press design
9/87-6/88 Materials Lab, Inc. - Analyst - Analyzed and designed plasma arc cutters
9/86-9/87 Walker Power, Inc. - Mechanical Designer - Designed textile wrap-spin machine
6/79-9/86 KRL Electronics, Inc. - Technician - Designed automated resistor equipment
OTHER WORK RELATED EXPERIENCE:
Thesis Topic: Strength of Medical Thermoplastic Female Luer Fittings Exposed to Chemicals
Lectured MD&M Show Seminar on The Science of Successful Product Design
Contact this candidate