Ken Goodman

Ken Goodman Email and Phone Number

Medical Device Product Development & Technical Leadership @ Ameda, Inc.
Ken Goodman's Location
Greater Chicago Area, United States, United States
Ken Goodman's Contact Details

Ken Goodman personal email

About Ken Goodman

Medical device product development engineer and technical leader specializing in leading varied and complex projects through the product development process.◄ Project management of multi-functional teams - product development & launch, international production, technology transfer◄ Product design documentation; V&V, test method development, specifications for design, manufacturing, purchasing; DFMEA, PFMEA, IQ/OQ/PQ, SOPs, Work Instructions◄ Product transition of 11 devices from design to full production, 4 to pilot production; fields include cardiology, urology, biomaterial applicators, breast pumps◄ Prototyping 18 platform devices for successful proof of concept trials◄ Compliance; EU MDR, 21 CFR 820, ISO 13485, 14971, 11135, 11607, 10993, REACH, RoHS◄ Planning and leading design verification, process validation, production qualification, MRB investigations, root cause analysis, DMAIC, CAPA, customer complaint resolution, risk analysis◄ Statistical analysis - linear regression, ANOVA, non-parametric & t-tests, design of experiments◄ SolidWorks/CAD, Minitab, MS Office, MS ProjectSpecialties: ▪Medical device product & process development▪Project management, design control, validation & verification▪Operations streamlining & improvement▪Compliance to QMS, EU MDR, 21 CFR 820, ISO 13485, 14971, 11135, 10993, REACH & RoHS

Ken Goodman's Current Company Details
Ameda, Inc.

Ameda, Inc.

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Medical Device Product Development & Technical Leadership
Ken Goodman Work Experience Details
  • Ameda, Inc.
    Research And Development Engineer
    Ameda, Inc. Jun 2021 - Present
    Buffalo Grove, Il, Us
    •Lead mechanical engineer on team which brought first new multi-user breast pump in 10 years from design to manufacture and product launch. •Responsible for planning, budgeting, and qualifying all design and manufacturing changes to high volume sterile disposable plastic components and packaging.•Managed international and domestic suppliers, leading design changes and product enhancements through clear communication and expectations.•Created technical documentation as part of product development including test protocols & reports, design changes, laboratory studies, product specifications based on scientific literature.•Conducted validation testing for combination product; completed IQ/OQ/PQ for custom molded components.•Wrote manufacturing and test procedures, design and purchasing specifications, BOMs, PFMEA.•Troubleshooting and solving indeterminate test results, comparing scientific literature to internal and competitive product, characterizing pump and disposable kit performance.•Evaluated specification changes requested by FDA, planned and executed testing to support those changes resulting in 510(k) approval.•Data based decision making using statistical analysis, financial analysis, international test standards
  • Gofli
    Owner
    Gofli Jun 2018 - May 2021
    Designed, produced and validated 6 cable protectors including first ready to market product to extend usable cable life. Filed patent, received trademark, incorporated as LLC, built cost model, created business branding and social media content, created website, surveyed market for initial feedback.
  • Self-Employed
    Head Of Household
    Self-Employed Jul 2014 - May 2018
    Home-based parent. Completed several projects including gut rehab of landmark house.
  • Teampraxis
    Client Services Project Manager
    Teampraxis Dec 2011 - Jun 2014
    Honolulu, Hawaii, Us
    Managed and supported implementation of EHR integrated program for healthcare practices.
  • Micromedics
    Design Engineer
    Micromedics Dec 2007 - Jun 2011
    Westlake, Oh, Us
    Brought multiple products from design to market launch. Filed for and received 510(k) approval. Led sterilization & biocompatibility validations, REACH & RoHS certification, created design control procedure linking product requirements to DV tests. Created accurate financial model showing real cost differential.
  • Boston Scientific
    Principle Process Development Engineer
    Boston Scientific 2006 - 2007
    Marlborough, Ma, Us
    CAPA; reduced lubricant coating scrap by isolating critical surface defects and confirmed other product passed testing. Improved balloon and stent product profiles through process development. Specified new equipment.
  • Aran R&D
    Project Manager
    Aran R&D 2004 - 2006
    Caesarea, Il
    Initiated and led new business segment for catheter-based development. Focus of projects was developing a concept into a prototype and turning it into a viable product. Mapped potential customer base and marketed these and other services to them. Wrote project proposals for cost, lead times and technical solutions. Built R&D assembly lab for quick turnaround of these prototypes.
  • Mel, Medical Enterprises Ltd.
    Mechanical Engineer
    Mel, Medical Enterprises Ltd. 2001 - 2004
    Transferred electronics production from Italy to Israel by rebuilding manufacturing & QC. Solved manufacturing and design issues using statistical tools. Established databases to track status of critical product outputs and alert to significant changes. Made and tested in-vitro simulation models to validate test methods. Designed and tested next generation bladder cancer treatment machine to be more reliable, modular, and lower cost and size.
  • Biometrix
    Qa Supervisor
    Biometrix 1999 - 2001
    Us
    Supervised quality control for all company products; drainage devices, tubing lines, and infusion products. Led CAPA teams to resolve customer complaints & Material Review Requests, established new specifications. Prepared QC department for annual audit. Specified and ordered parts for initial catheter production.
  • Scimed
    Process Development Engineer, Qa Engineer
    Scimed Jun 1990 - Oct 1997
    Us
    QA - Planned & led process validation & production qualification for 5 catheters through product launches. Analyzed product failures, implemented CAPA, data-based decision making using statistical tools.Process Development - Led teams in transition of 3 new catheters from design through product launches.
  • Interventional Innovations Corp
    Manufacturing Engineer
    Interventional Innovations Corp 1996 - 1997
    Transfer of company’s first product, drug delivery catheter, from pilot to full scale production. Specification, development, and implementation of production fixturing. Planned & led process validation, wrote maintenance SOP’s, equipment IQ/OQ, and cleanroom practices. Developed & implemented new processes; heat forming spiral, tube printing, lubricant coating & curing.
  • Advanced Cardiovascular Systems
    Intern
    Advanced Cardiovascular Systems 1987 - 1990

Ken Goodman Skills

Writing Transferring Market Suppliers Corrective Actions Printing Phantom T Tests Cardiology Modular Sales Functional Verification Cost Plastics Research Development Hebrew Coatings Antennas Minitab Failure Non Parametric Complaints Spiral Treatment Cancer International Production Management Die Maple Design Disposables Simulations Science Drilling Fixtures Catheters Statistics Integration Sop Resolve Auditing Boston Baseline Multifunctional Qualification Material Selection Process Validation Languages Troubleshooting English Interventional Pdm Team Management Tests Validation Engineering Defect Supervision Drug Delivery Medicine Variables Testing New Business Development Piloting Transitions Clean Rooms Assembly Project Management Product Development Quality Control Product Launch Capital Mel R&d Analysis Through Design Process Simulation Inspection Sterilization Design Control Trials Soldering Linear Regression Data Analysis Market Launch Product Costing Mechanical Trimming Business Development Compression Shape Market Mapping Scientific Scrap Bladder Machine Design Forming Quality System Marketing Curing Project Planning Stripping Project Surface House Solidworks Insulation Technology Transfer Corrective Action Technical Solutions Injection Molding Minneapolis Regulations Product Requirements Heat Target Costing Reviews Proof Of Concept Defects Adhesive Bonding Gmi Diagnostics Biocompatibility Materials Medical Devices Software Product Design Statistical Data Analysis Mechanical Engineering Proposal Writing Manufacturing Interest Rates Decision Making New Equipment Production Lines Conceptual Modeling Customer Base Mrp Fda Prototype Databases

Ken Goodman Education Details

  • Kettering University
    Kettering University
    Mechanical Engineering

Frequently Asked Questions about Ken Goodman

What company does Ken Goodman work for?

Ken Goodman works for Ameda, Inc.

What is Ken Goodman's role at the current company?

Ken Goodman's current role is Medical Device Product Development & Technical Leadership.

What is Ken Goodman's email address?

Ken Goodman's email address is ke****@****ail.com

What schools did Ken Goodman attend?

Ken Goodman attended Kettering University.

What skills is Ken Goodman known for?

Ken Goodman has skills like Writing, Transferring, Market, Suppliers, Corrective Actions, Printing, Phantom, T Tests, Cardiology, Modular, Sales, Functional Verification.

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