Reidar Saito Aamotsbakken
Technology Assessment Program Manager, Medical Devices at UW Health
Technology Assessment Program Manager, Medical Devices at UW Health
Medical device domain expert with over twenty years of broad experience in medical device hardware and software, along with eight years of people management.  MS Biomedical Engineering and BS Chemistry.   Product development experience includes FDA class II and III devices, hardware and software design, integrated systems, and consumables.
UW Health
https://www.linkedin.com/company/uw-health
Manager of the technology assessment program for the UW Health system, I manage product requests from physicians for medical devices that fall under the capital budget.  I facilitate the monthly technology assessment committee meetings where a group of 60 vote on large purchases.   As an integral part of our newly transformed Clinical Quality Value Analysis department, I also work with the team on all other requests for medical devices, evaluations and purchase.
Madison, Wisconsin Area
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Technology Assessment Program Manager, Medical Devices
Salus Discovery
https://www.linkedin.com/company/salus-discovery
Project: FLOW TB, a low-cost, disposable analyte concentrator and lateral flow assay for tuberculosis screening in low resource countries using urine sample. Clinical site in South Africa with multiple collaborators Worldwide. Funded by the Bill and Melinda Gates Foundation. 
Developed FLOW TB from a non-working concept to a working device, detecting the lowest analyte concentrations recorded to date in a disposable device.  Supplied clinical site in South Africa with small batch manufacturing.
Madison, Wisconsin Area
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Engineering / Manufacturing
Cellara
Company founder and initially President.  Cellara’s CultureTrax Laboratory Information Management System is a cloud-hosted Software-as-a-Service platform for cell culture science, built around the advanced workflows of stem cell culture using a graph database with document storage backend. Functioned as product owner and led the development of the CultureTrax platform from start through soft commercial launch using analysis of Voice of Customer and Key Opinion Leader input in a Lean startup environment with agile development offsite by Acumium, Madison, WI. Worked on strategy, grant opportunities, and early sales projections. Responsible for 60% of the company’s budget.  CultureTrax is now owned and operated by Acumium.
Madison, Wisconsin Area
Chief Technology Officer
Swift Manufacturing & Engineering, Inc.
https://www.linkedin.com/company/swift-manufacturing-&-engineering-inc-
Co-founder, sIlent partner while working for Carefusion 2011-2012.  Worked full time for the company again from July 2012 through December 2013, overlapping with the startup of Cellara.
Managed the day-to-day operations of a manufacturing company, including sales of manufacturing and engineering contracts; manufacturing equipment purchase, setup and maintenance; raw material and tooling purchase and stock control; inventory control; waste reduction efforts; product deliveries and accounting. Initiated and administered the company’s State of WI apprenticeship program for machinists. Swift produces components for a number of industries using CNC mills and CNC turning centers.
3300 Commercial Ave. Madison, Wisconsin 53714
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Vice President
CareFusion
https://www.linkedin.com/company/carefusion
Managed the nine person software QA team for the Nicolet neurology division until the sale of the business unit to Natus Medical. Program Manager for the sustaining engineering effort for the Nicolet One legacy application. Responsible for all ISO 13485 and 21 CFR 820.30 design controls on all projects for the Nicolet business unit. Member of the ISO 14971 risk management team. Core team member NicVue 3.0 application development. Core team member, Nicolet EEG wireless ambulatory amplifier hardware development. Team member on Carefusion Corporation’s worldwide design control team, developing the company’s new Global design control system for a company with 15,000 employees. Auditor and final sign-off on all DHFs.  Reported to Sr. Director, Quality and RA.  Carefusion is now BD, Nicolet is now Natus Neurology.
Middleton, WI
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Design Assurance Manager
Design Concepts
https://www.linkedin.com/company/delvedesign
Primary source of reference for all medical device contracts. Conducted forums and educational sessions relating to biologics, biomaterials and medical devices. Sales contact for medical device clients. Functioned as project manager for the highest visibility medical device development contracts. 
Managed the development of the surgical interface for the Lotus Edge Valve, a differentiated second-generation Transcatheter Aortic Valve Replacement (TAVR) device.  Client: Sadra Medical, acquired by Boston Scientific in November 2010.  Edison Silver Award for surgical tools, 2015.
Madison, Wisconsin Area
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Program Manager, Medical Device
University of Wisconsin - Madison
https://www.linkedin.com/company/uwmadison
Started and built the Medical Device and Biotechnology continuing education program in the College of Engineering's EPD department. Provided courses and workshops for industry professionals. Reported to EPD department Chairman. Program closed 6-2009 due to recession.  
Developed continuing education curriculums and conducted 2-4 day classes across the US. 
Sampling of topics: Process Sampling for Medical Device, Biotechnology and Physiology for Engineers, ISO 13485 and 21 CFR 820, Introduction to Medical Imaging Systems, Principles of Radiation Therapy Systems, Designing Medical Devices: an Innovation course, Minimally Invasive Devices, Combination Products, Cardiovascular Devices, Drug Eluting Devices, GI and Urinary Devices, Neurovascular Devices, Biomaterials.  
Conducted training for Johnson & Johnson on physiology and development of cardiovascular devices.  
Conducted training for Tomotherapy (Accuray), Madison, WI.
Madison, Wisconsin Area
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Program Director, Medical Device
Gammex Inc
https://www.linkedin.com/company/gammex-inc
Gammex RMI is a medical device company focusing on imaging and radiation therapy QA tools and X-ray dose control instrumentation.  Member of the senior management team, reported to CEO. Directed all manufacturing engineering, sustaining engineering, and product development efforts according to IEC 60601, ISO 13485, 21 CFR 820. Supported sales and marketing when needed as technical specialist. 
Managed a cross-functional team of eight engineers representing over 130 years of industry experience.   
Hands-on process engineer in the manufacturing plant, effectively breaking down old barriers between engineering and manufacturing in a well established company. 
Co-investigator on NIH STTR phase II grant 2R42HD040747-02 for development of tools to reduce radiation dose in computed radiography imaging of premature neonates. Presented at RSNA 2005.
Developed an electron density calculator to design new tissue mimicking plastics.
Madison, Wisconsin Area
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Engineering Manager
TREK Diagnostic Systems
https://www.linkedin.com/company/trek-diagnostic-systems
TREK Diagnostic Systems is an in vitro diagnostic company catering to microbiology labs. Hands-on process engineer using Six Sigma and Lean techniques in an aseptic liquid-fill manufacturing facility. One direct report. Reported to CSO, member of the site management team at the Sun Prairie manufacturing plant.
Managed the manufacturing process development of six high-volume aseptic liquid consumable products supporting the Sensititre product line according to 21 CFR 820 and ISO 13485 standards.  Managed the project from business plan through validated products, including shelf life, packaging and shipping studies.  Selected equipment and set up two manufacturing lines, including IQ, OQ, PQ, scale-up and process validation for cleanroom and terminal sterilization. Project improved quality, increased shelf life, and improved margins as compared to previously outsourced product, eventually resulting in a doubling of sales. 
Instrumental in the transfer of Combact Diagnostic’s Cellenium technology and manufacturing from Israel.  
Corrosion studies, material selection and shelf life studies for VersaTREK consumables.
Sun Prairie, WI
Senior Process Engineer / Manager
PowderJect Vaccines
https://www.linkedin.com/company/powderject-vaccines
PowderJect Vaccines was a division of PowderJect Pharmaceuticals LLC, Oxford England. Developed proprietary drug filling processes and highly specialized pilot scale manufacturing equipment for the PowderJect intradermal particle bombardment drug delivery device. Managed outside contracts in the US and England for design of process equipment for aseptic microgram dose production. Designed and built manufacturing automation equipment, combining mechanical, electrical, and pneumatic design as hands-on engineer. Conducted equipment IQ, OQ, PQ and process validations in cleanroom environment. Worked on scale-up from bench scale to pilot scale of aseptic process. Reported to VP R&D & Manufacturing.
Process Development Engineer II
International Flight Center, Murfreesboro, TN
Flight and Ground Instructor.  Single- and multi-engine, instrument
Flight Instructor
MS
Joint program in biomedical engineering with University of Memphis.
Biomedical Engineering
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The University of Tennessee Health Science Center
https://www.linkedin.com/school/university-of-tennessee-health-science-center/
MS
Joint program in biomedical engineering with University of Tennessee Health Science Center.  Worked under Prof. Steven Slack (1998). Biomaterials and tissue engineering track. Thesis: Fibrinogen adsorption to biomaterials; effects of albumin co-adsorption.  Invented a new testing technique allowing for a ten-fold increase in sampling while reducing radiolabeled biohazard waste.  Managed the radioisotope lab.
Biomedical Engineering
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The University of Memphis
https://www.linkedin.com/school/the-university-of-memphis/
BS
Chemistry
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Middle Tennessee State University (MTSU)
https://www.linkedin.com/school/middle-tennessee-state-university/
Advanced Lateral Flow Course
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Combination Products: Devices, Drugs, and Biologics
University of Wisconsin
Designing Cardiovascular Devices
University of Wisconsin
Designing Gastrointestinal and Urinary Devices
University of Wisconsin
Designing Neurovascular Devices
University of Wisconsin
Designing Peripheral Vascular Devices
University of Wisconsin
Emerging Trends in the Medical Device Industry
University of Wisconsin
Fundamentals of Medical Imaging Systems
University of Wisconsin
Introduction to Biotechnology
University of Wisconsin
Principles of Radiation Therapy Systems
University of Wisconsin
Process Validation Principles
University of Wisconsin
Successful Acceptance Sampling
University of Wisconsin
https://uk.linkedin.com/in/jonathan-ellis-386b025a
Greater Bournemouth Area
Jonathan Ellis
Senior Account Manager at imageHOLDERS Ltd
https://in.linkedin.com/in/thomas-varghese-8ba18b158
Kochi
Thomas Varghese
Technology Architect | Founder at LyfGrid
https://www.linkedin.com/in/chrisleger2
Greater Lansing
Christopher Leger
Clinical Engineering (CE) | Healthcare | Biomedical Program Development & Consulting | Strategic Sourcing CE Services
https://www.linkedin.com/in/betsylane
New Egypt, NJ
Betsy Lane
Senior Director and Chief Marketing & Communications Officer at ISPOR
https://www.linkedin.com/in/laura-bourdeanu-7a880138
Rensselaer, NY
Laura Bourdeanu
Online Faculty at American Sentinel University
https://www.linkedin.com/in/clarissa-cooblall
United States
Clarissa Cooblall, MPH, CHES
Associate Director, Scientific and Health Policy Initiatives at ISPOR
https://www.linkedin.com/in/adam-heitner
Roslyn Heights, NY
Adam Heitner
Account Executive at Consolidated Technologies, Inc. (CTI)
https://www.linkedin.com/in/tressagill1
Madison, WI
Tressa Gill
Director Perioperative Services  at UnityPoint Health – Meriter
https://es.linkedin.com/in/rebecca-neri-97a61a1b5
Spain
Rebecca Neri
Graduate student
https://www.linkedin.com/in/amy-yeska-8791501b
Madison, WI
Amy Yeska
Acute Care Sales at Medline Industries, Inc.
https://in.linkedin.com/in/bharath08
Chennai
M Bharath Kumar
Client Services- Lapiz Healthcare
https://www.linkedin.com/in/gormican-joe-34b97130
San Diego, CA
Gormican Joe
Anything is possible with enough time or money.
https://www.linkedin.com/in/kcederquist
Carlsbad, CA
Kristin Cederquist
Senior Scientist at DCN Diagnostics
https://www.linkedin.com/in/gary-robb-a0105214
Madison, WI
Gary Robb
VP, Chief Pharmacy Officer
https://www.linkedin.com/in/mdhardin
San Francisco Bay Area
Matt Hardin
Leadership for programs, teams, and products
https://www.linkedin.com/in/kelechi-iweajunwa-ukoha-sr-31509b44
Houston, TX
Kelechi Iweajunwa Ukoha Sr.
Successful Program Manager with aspirations of leading a health plan to improve access to care and be a leader in the healthcare industry by driving efficiency in the execution of initiatives (net new and regulatory).
https://www.linkedin.com/in/mjadala
Greater Chicago Area
Madhur Jadala
Regional Technology Manager at AMITA Health
https://www.linkedin.com/in/braulio-polanco-81ab2725
Greater Boston
Braulio Polanco
Program Manager at Medtronic
https://www.linkedin.com/in/duane-bigelow-ab57295
Greater Phoenix Area
Duane Bigelow
Senior Engineering Program Manager at Medtronic (22,000+)
https://www.linkedin.com/in/jamesothomas3
United States
James Thomas
Program Manager
Troy Oleck
      
          



            
              
        
              
  

    
        Reidar was an excellent Enginering Manager while at Gammex. Not only did he help sales with technical questions on the product, but he was able to point out advantages that our products had over the competition. This ultimately helped in closing sales.  

Currently, Reidar's seminars are the talk of the Medical Device community. I would highly recommend attending any program that he is coordinating.
University of Memphis Alumni Group
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The Norwegian-American Chamber of Commerce, Inc. (NACC)
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https://www.linkedin.com/groups/1053587
Cardiovascular Medical Devices Group
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https://www.linkedin.com/groups/675087
MTSU Alumni
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https://www.linkedin.com/groups/44037
Design Controls for Medical Devices
https://static-exp1.licdn.com/sc/h/4h1ldzvvebtszyx75ve7dst1v
https://www.linkedin.com/groups/2053976
Medical Device Innovations
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https://www.linkedin.com/groups/84299
Medical Device Link
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https://www.linkedin.com/groups/42765
Medical Device Inventors
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https://www.linkedin.com/groups/132367
BioForward
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https://www.linkedin.com/groups/70287
Medical Device Engineers & Consultants
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https://www.linkedin.com/groups/139148
Midwest Life Science Network (LSN)
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The Life Science Executive Exchange, sponsored by BioInformatics Inc.
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https://www.linkedin.com/groups/72923
Medical Device Development & Manufacturing Group
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https://www.linkedin.com/groups/2584891
MEDICAL DEVICE INNOVATION CENTER
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https://www.linkedin.com/groups/3405458