Engineer Manufacturing
Resume:
Resume of Joe Johnson Page * of *
Joseph C. Johnson
*** ********* ***, ******** ** 95035
*******@*****.***
OBJECTIVE: To achieve excellence as an Engineer.
QUALIFICATIONS:
B.S. Chemical Engineer from U.C Davis, and a talented problem solver. PROFESSIONAL EXPERIENCE:
MANUFACTURING ENGINEERING MANAGER
INVUITY INC., OCT 2014 – PRESENT
Invuity is a very fast moving manufacturing business delivering Intelligent Photonics products that work with and without our custom line of retractors to better illuminate open surgeries.
I manage three engineers, a technician and manufacturing engineering contractor. We work in a highly collaborative environment teaming with Quality, R&D, Materials, Marketing, Regulatory and Management on every project, every decision.
We’ve provided the resources for continuous grown earning $32.46M in 2016, up from $21.03M in 2015,
$13.1M in 2014 and $7.19 in 2013.
I have transferred facilities from the old loft space to the large-scale facility located at 444 De Haro Street in San Francisco, including the material flow built into the facility with parts receiving, QA inspection, raw materials Kan Ban, cleanroom pass-thru to packaging and labeling to the sterilization pallet station.
Established a little machine shop with a band saw mill and a lathe. I had to fight for this as a problem solving tool and it has paid off in spades.
SR. MANUFACTUING ENGINEER
INVUITY, INC. Feb 2011-Oct 2014
Sourced, purchased, installed and validated (IQ, OQ, PQ, & PPQ) every new piece of manufacturing equipment including the Laser Etcher, Chatillon, Belco tray sealer, UV lights, hot box, EFD Machines, Ultrasonic Cleaners, Programmable Ovens, Autoclave and many others.
Designed and fabricated multiple custom fixtures using SolidWorks.
Operations engineering support for new device introductions and line expansions. Written, performed and supervised execution of protocols per the Design Inputs for Design Verification, Process Validation, Packaging Validation and Shelf Life.
Owner of the process risk analyses.
Owner of the packaging and labeling processes, transferring the company’s products from pouches to thermoformed trays.
Expanded manufacturing to a contract manufacturer, purchase and validation, IQ/OQ/PQ of off-site equipment, device PQ and PPQ validations. Transferred the Labeling Process.
Operations support for authoring and maintaining the company’s quality systems, addressing the NMRs, closing CAPAs, writing the needed work instructions, SOP’s and forms SR. MANUFACTUING ENGINEER
SATIETY INC. May 2008-Dec 2010
Responsible for manufacturing the TOGA Sleeve Stapler, a trans-oral gastroplasty device, used to treat obesity.
Lead Technical Engineer for Injection Molded Handle Project which would have reduced the cost of the TOGA Sleeve Stapler by over $400.00 per device.
Resume of Joe Johnson Page 2 of 2
Operations lead to launch the TOGA Sleeve Stapler. Production Transfer Phase Review completed December 2010.
Owned the Master Validation Plan, validated all processes accordingly and maintained the state of validation, using statistically valid data.
Managed the vendor supply of the most complex parts of the TOGA Sleeve Stapler, the Pods, through the initial machining, laser welding, leak testing and inspection.
Executed the device validation protocols at the cadaver lab.
Handled the day to day operations for manufacturing, the DCOs, NCMRs, CAPAs, supply chain, rework and fixture designs and company metrics.
R&D ENGINEER III
CHOLESTECH CORP. June 2004 – May 2008
R&D Design Engineer and Promoted to Process Development Engineer. Cholestech made over one million cholesterol testing devices every 10 days for use with the LDX desktop system to measure cholesterol and other blood proteins from a finger stick.
Worked directly with the General Manager as the Lead Technical Engineer for several high profile projects including the New Cassette Design for part compaction and higher production rate, New Cassette Design for lateral flow through the centerglass, validation of the Pilot Line for production of Lipid ALT, HemoSence launch of the InRatio 2, the Microfluidic Cassette, the Direct LDL Cassette, and the successful launch of the hs-CPR cassette.
Designed novel part design concepts: for part compaction minimizing pitch to maximize yield and rate for future production; for microfluidic plasma separation and transport; and for the next generation hs-CRP cassette.
Working with Kinematic Automation, I designed, delivered, and validated two pieces of production equipment for hs-CRP that were previously overlooked, capable of making 2 complex laminations at a rate of 1 part every 5 seconds.
Performed the tolerance stack analysis solving the “No Scratch” problem on the InRatio 2 (a Hemosence Product).
Share 50% responsibility for all of the Company’s drawings in SolidWorks, PDFs, and AutoCAD. SR. MANUFACTURING ENGINEER
KYPHON INC. Nov 1999-Feb 2003
Sr. Manufacturing Engineer
I was employee number 50 of Kyphon and supported the production ramp-up from $500K in 1999 to over $36M in 2001 and $76M in 2002.
SR. MANUFACTURING ENGINEER & MANUFSCTURING ENGINEERING MANAGER CARDIAC PATHWAYS CORPORATION Apr 1997 Feb 1999- Oct 1999 Sr. Manufacturing Engineer
I was hired as Manufacturing Engineer responsible for 7 French deflectable catheters used for RF ablation of cardiac arrhythmias including the “Chilli” cooled tip catheter which is still on the market today sold by BSC. I was promoted to Sr. Manufacturing Engineer and Manufacturing Engineering Manager. MANUFACTURING ENGINEER/LINE MANAGER
ENDOSONICS CORPORATION FEB. 1995-1997
Manufacturing Engineer/Line Manager
Responsible for building the world’s smallest solid state ultrasonic transducer for heart surgeries. I started a swing shift supervisor and left the organization as one of the line managers manufacturing the basic device.
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