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Ken Goodman

Ken Goodman
  • Technical leader with over 20 years of medical device experience specializing in leading projects through the product development process. Expertise in catheter based technologies, proven experience in all phases of the product development cycle.
  • Product transition of 10 devices from design to full production, 4 to pilot production
  • Prototyping 18 platform devices for successful proof of concept trials
  • Planning and leading design verification, process validation and production qualification activities
  • Project & team management - product transitions, international production & technology transfer
  • Development of new processes for making, testing catheters
  • Statistical analysis by linear regression, ANalysis Of VAriance, t-tests, etc.
  • Led corrective action teams in resolution of customer complaints, Material Review Requests
  • Business development – market mapping, marketing, writing project proposals, product costing

EXPERIENCE
12/2007 – 6/2011

Micromedics, a Nordson Company, St.Paul, Minnesota
Project Engineer, Design Engineer

  • Brought 3 products through design to market launch, leading company sales
  • Led development group’s sterilization & biocompatibility validations for all new products; initiated REACH & RoHS compliance material certification & testing
  • Product development includes graft preparation and delivery device, new applicator to dispense biomaterials, spray nozzle with reduced droplet size, endoscopic applicator with combination of rigid and flexible segments
  • Developed high speed photography capability to measure spray droplet size
  • Developed novel process to increase bond strengths & consistencies
  • Modeled costing to more accurately show actual change in expenditures for better decision making
  • Drafted design control procedure to link initial product requirements through their design verification
  • Submitted & received FDA regulatory approval on 510(k) for company’s first device in new class

9/2006 – 11/2007

Boston Scientific, Maple Grove, Minnesota
Principal Process Development Engineer

  • Reduced hydrophilic coating scrap; developed method to distinguish critical defects from cosmetic ones. Performed tests and researched complaint data proving potential particulate failure mode was non-existent or occurred at lower rates than control samples.
  • Led stent integration, form-folding processes on new product. Reduced profiles significantly through process, machine modifications. Investigated and solved product surface defect issues; specified new equipment and prepared capital expenditure authorizations.

9/2004 – 8/2006

Aran Research Development & Prototypes, Caesarea
Project Manager, Medical Devices

  • Initiated and led new business segment for catheter-based development. Focus of projects was building a first prototype taken as an idea and turned into a viable product.
  • Prototyped 15 platform devices for over 6 fields using a variety of balloon materials and processes
  • Platform devices made for quick assembly of near-term builds, to easily transition into a product which is designed for manufacture and reliability for long term builds
  • Initial prototypes made to prove concept, show investors and their technical experts.
  • Market mapping potential customer base and marketing these and other services to them
  • Writing project proposals for cost, lead times and technical solutions
  • Built R&D assembly lab for quick prototype turnaround

10/2001 – 7/2004

MEL, Medical Enterprises, Ltd., Petah-Tikva
Mechanical Engineer

  • Transferred production of disposable electronics from Italian to local supplier through completely rebuilding production lines, QC stations, manufacturing and testing procedures and fixtures.
  • Troubleshooting and corrective action of production & product issues through statistical data analysis of input variables vs. outputs, and verification through testing hypotheses
  • Establishing inspection and testing databases to define status & changes of critical product variables
  • Making and testing phantom simulation models to check existing test methods
  • Design, assembly and testing bladder cancer treatment machine improvements for next generation machine to be more reliable, inexpensive, smaller and modular

12/1999 – 9/2001

Biometrix Medical, Ltd., Jerusalem QC Supervisor

  • First line supervision of all pre-sterilization quality control activities for all company products, including drainage devices, tubing lines, and infusion products
  • Led teams to resolve customer complaints & Material Review Requests (MRR’s) through corrective actions, establishing baseline data and new specifications
  • Preparation of department for annual quality system audit
  • Specifying and ordering parts for first catheter to be manufactured in-house

6/1990 – 10/1997

SCIMED Life Systems, Boston Scientific Corporation, Maple Grove, Minnesota

12/1994 – 3/1996, 1997 Quality Engineer, Diagnostic & Cardiology Divisions

  • Planned & led process validation & production qualification for 5 catheters
  • Troubleshot product failures, specified & implemented corrective action
  • Decision making based on statistical data analysis such as linear regression models, ANalysis Of Variance, t-tests, non-parametric tests, etc.

6/1990 – 2/1995 Process Development Engineer, Cardiology Division

  • Project management – led core and extended team in transition of new catheter from design to full scale manufacture, and ultimately through successful product launch
  • Development of processes including hole drilling, heat & adhesive bonding, heat shrinking, shape & compression forming, die necking, injection molding, freeblowing, lubricant coating, trimming, core removal, insulation stripping, soldering, winding

3/1996 – 1/1997 Interventional Innovations Corp., St.Paul, Minnesota; Manufacturing Engineer

Transferring company’s first product, drug delivery catheter, from pilot to full scale production

  • Design specification, development, debug & implementation of production fixturing.
  • Writing and implementing process validation plan, SOPs for maintenance, equipment IQ/OQ, and cleanroom practices.
  • Developing & implementing new processes; heat forming spiral, tube printing, lubricant coating & curing

EDUCATION

1985 – 1990 GMI Engineering & Management Institute, Kettering University; Flint, Michigan Bachelor of Science in Mechanical Engineering, Machine Design Cognate

1992 – 1994 University of Minnesota, Minneapolis & St.Paul Campuses

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