Ken Goodman Email and Phone Number
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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
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Research And Development EngineerAmeda, Inc. Jun 2021 - PresentBuffalo 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 -
OwnerGofli Jun 2018 - May 2021Designed, 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.
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Head Of HouseholdSelf-Employed Jul 2014 - May 2018Home-based parent. Completed several projects including gut rehab of landmark house.
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Client Services Project ManagerTeampraxis Dec 2011 - Jun 2014Honolulu, Hawaii, UsManaged and supported implementation of EHR integrated program for healthcare practices. -
Design EngineerMicromedics Dec 2007 - Jun 2011Westlake, Oh, UsBrought 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. -
Principle Process Development EngineerBoston Scientific 2006 - 2007Marlborough, Ma, UsCAPA; 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. -
Project ManagerAran R&D 2004 - 2006Caesarea, IlInitiated 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. -
Mechanical EngineerMel, Medical Enterprises Ltd. 2001 - 2004Transferred 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.
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Qa SupervisorBiometrix 1999 - 2001UsSupervised 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. -
Process Development Engineer, Qa EngineerScimed Jun 1990 - Oct 1997UsQA - 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. -
Manufacturing EngineerInterventional Innovations Corp 1996 - 1997Transfer 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.
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InternAdvanced Cardiovascular Systems 1987 - 1990
Ken Goodman Skills
Ken Goodman Education Details
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Kettering UniversityMechanical 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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