Steve Johnson work email
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Medical Device Executive experienced with product development, manufacturing and quality systems for implantable, disposable and reusable devices. Proven leadership in a collaborative, cross-functional team environment where high quality, low cost and dependable product supply are essential.Specialties: Extensive experience bringing new medical devices out of the lab into production to support clinical trials and market launches of diagnostic and therapeutic devices.
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Vice President, OperationsObalon Therapeutics Jan 2014 - Dec 2017Carlsbad, CaVP Ops during design verification and process validation of a refined device design and processes. FDA double blinded, randomized sham-controlled trial trial of 387 patients treated with >1000 devices and no SAEs. PMA approval within 180 days and a successful FDA QSR audit enabled a $75 million IPO and $10 million revenue commercial launch in 2017 of the most promising medical device for weight loss. -
Chief Operating OfficerIrhythm Technologies, Inc. Jan 2011 - Dec 2012San Francisco Bay AreaResponsible for product development, manufacturing, quality assurance, regulatory affairs and clinical operations for this emerging medical device company. iRhythm products incorporate breakthrough technology that improves the diagnosis of cardiac arrhythmias by providing up to 14 days of continuous ECG recording which increases the likelihood of capturing abnormal heart rhythms. -
PrincipalIndependent Consultant Sep 2009 - Dec 2010San Francisco Bay AreaMedical device consultant for early stage companies on challenges related to product and process development, manufacturing and quality systems.
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Sr. Vice President, OperationsAptus Endosystems Sep 2008 - Aug 2009Sunnyvale, CaResponsibilities at this clinical stage company included manufacturing and quality assurance during preparation for a commercial launch in Europe. Accomplishments included process validations and successful ISO surveillance and MDD audits leading to a CE mark by TÜV.
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Sr. Vice President, OperationsHeartport Aug 1994 - May 2001San Francisco Bay AreaResponsibilities involved manufacturing, quality assurance, corporate real estate and facilities after joining this development stage company. Drafted, reviewed, approved and/or implemented quality system procedures leading to ISO certification and FDA/QSR compliant quality system. Brought over one hundred part numbers from prototypes to market in four product families in two years. Consistently improved product quality and reduced cost over each product’s life cycle.
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Sr. Vice President, ManufacturingGuidant (Advanced Cardiovascular Systems) May 1983 - Aug 1994San Francisco Bay AreaResponsibilities at this start up grew to include product development, manufacturing, quality assurance, and facilities. Job scope involved over 1200 employees, $100 million annual budget, and $100 million of real estate and facilities. During tenure as VP, revenue, production throughput and the number of product offerings more than doubled. Same day shipments improved from 80% to 98% of orders and Customer complaints were reduced by 75%. Market share exceeded 60% and gross margins surpassed 80%. The company received its certification to ISO 9001/EN 46001.
Steve Johnson Skills
Steve Johnson Education Details
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Industrial Engineering
Frequently Asked Questions about Steve Johnson
What is Steve Johnson's role at the current company?
Steve Johnson's current role is Retired.
What is Steve Johnson's email address?
Steve Johnson's email address is sj****@****lon.com
What schools did Steve Johnson attend?
Steve Johnson attended Kettering University.
What skills is Steve Johnson known for?
Steve Johnson has skills like Medical Devices, Fda, Iso 13485, Design Control, Product Development, R&d, Quality System, Commercialization, Market Development, Start Ups, Capa, Manufacturing.
Not the Steve Johnson you were looking for?
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Steve Johnson
United States -
Steve Johnson
Founder, President And Ceo Of Total Data Migration - The Global Leader In Data Recovery, Restoration, Migration, Conversion, And Secure DisposalAtlanta Metropolitan Area -
2enel.com, demand-energy.com1 (509) 8XXXXXXX
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Steve Johnson
Tampa, Fl7vein911.com, earthlink.net, ymail.com, cae.com, prioritycaresolutions.com, pharmaservices-us.com, hillcour.com9 +181332XXXXX
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Steve Johnson
San Francisco, Ca6housatonicpartners.com, gmail.com, marlinequity.com, patriotgis.com, gipartners.com, gipartners.com
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