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A dynamic and innovative product development executive specializing in the medical device industry, with comprehensive domestic and global expertise in product research and development, product lifecycle management, regulatory requirements, Lean manufacturing, risk management, quality assurance, and organizational development. Excels at managing talent and coaching/mentoring high-performing teams. Proven aptitude for delivering quality products on time and at or below budget while meeting all critical customer requirements. Consistently delivers forward-thinking solutions to improve quality/compliance, reduce costs, and optimize global resources.
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R&D Site LeadZoll Medical Corporation 2018 - 2021Deerfield, WiNew role as part of Zoll's acquisition of Cardiac Science. R&D Site Lead for Powerheart® AEDs, part of the Zoll family of Automatic External Defibrillators.Previously Consultant lead of the Powerheart® G3 Elite: the first new AED at Cardiac Science in over 7 years. Oversaw cross-functional development of the RoHS 2 compliant AED that received a CE Mark allowing for sales to the EU and Asia PAC regions. Addressed obsolescence of previous generation AED through updated Printed Circuit Board Assemblies (PCBAs), that improved performance and lowered Cost of Goods Sold (COGS). Incorporated the latest Cyber Security guidance from the FDA. Submitted as a PMA filing in 2019. -
Vice President, Clinical Integration And New Product Development, Global Device R&DHospira 2013 - 2017Lake Forest, IlOversaw new product development of next generation Plum/Lifecare PCA families of smart infusion pumps with Hospira MedNet safety software; pumps designed to integrate with electronic medical record (EMR) systems through IV Clinical Integration solutions. Administered product lifecycle management, including retirement of obsolete products and SKU consolidation.• Recognized for leading development of new Plum 360 infusion pump while simultaneously remediating quality system, resulting in successful product launches and lifting of FDA's import ban.• Obtained 510(k) clearance for Lifecare PCA 7.01 in April 2016 (first PCA pump in industry with EMR integration and auto programming, incorporating latest FDA cyber security guidance).• Obtained 510(k) clearance for Plum 360 infusion system with Hospira MedNet safety software in January 2015.• Received 510(k) clearance for MedNet Medication Management Suite in July 2014. -
Senior Vice President, Global R&DInvacare 2010 - 2012Elyria, OhioLed global engineering teams in North America, UK, France, Germany, Switzerland, Sweden, New Zealand, and China to deliver new products and sustain/improve existing products across all categories. Integrated engineering teams that were brought into Invacare through years of ad hoc acquisitions into a global team aligned with the overarching corporate goals of “One Invacare.” • Reorganized previously fragmented global product development teams into focused centers of excellence aligned with specific business categories:- Respiratory (stationary, transportable, and portable);- Assistive lifestyle products (safe patient handling, powered beds); and- Power and manual wheelchairs.• Optimized global resources to ensure highest ROI, eliminating redundancies and reallocating resources to meet critical business objectives. -
Senior Vice President, Global R&DFenwal, Inc. 2007 - 2010Lake Zurich, IlOversaw development of new blood collection devices, software releases, FDA 510(k) clearances, new drug approval, manufacturing improvements, and lifecycle management of on-market products. Led the optimization of global development teams, processes, and budget while meeting business objectives related to being sold to private equity firm, TPG.• Received first ever FDA New Drug Application (NDA) approval for PAS-III InterSol in U.S.• Formed dedicated sustaining engineering organization focused on product quality, delivery, and cost while successfully addressing numerous product obsolescence issues.• Formed/chaired Invention Review Board to manage and develop company’s intellectual property.• Led teams in product launches, including:- New blood collection device (Alyx RBC/Plasma product) providing new FDA 510(k) indication for use: concurrent red blood cell unit collected with plasma donation.- Alyx blood apheresis device redesign that increased reliability > 170%.- New v3.x software releases on plateletpheresis device (Amicus) featuring faster procedure time, streamlined workflow, and new graphical user interface.- Amicus data capture and reporting tool, DXT, increasing customer output by more than 20% and receiving new FDA 510(k) indication for use for wireless data communication to medical device. -
Vice President Of Engineering, Fenwal DivisionBaxter International Inc. 2001 - 2007Round Lake, IlLed new product development and sustaining engineering for automated blood collection devices, including Alyx, Amicus, Auto-C, and CS-3000. Directed software, EE, ME, systems engineering, and verification/validation teams. Led creation and deployment of first unified software product development process across all company divisions, improving development time and quality while addressing FDA compliance issues. Introduced DFMA into product development, resulting in significant device manufacturing and quality improvements (95% first pass yield). -
Director And Chief Architect, Cable Access Division3Com 1998 - 2001Rolling Meadows, IlLaunched company’s first voice over IP (VoIP) DOCSIS cable modem ahead of schedule and under budget. -
DirectorMotorola 1989 - 1998Schaumburg, IlProduct Manager, Multimedia Group Products Division, 1996-1998. Oversaw product definition and advanced development of videophone set-top box incorporating H.320 and H.324 standards-based business class services. Director, Technology Assessment, Motorola Multimedia Group, 1994-1996. Provided key due diligence input to group senior VP and GM for both internal and external investment decisions. Principal Staff Engineer, Wireless Data/Cellular Infrastructure Group, 1989-1994. -
Member Of The Technical StaffAt&T Bell Laboratories 1982 - 1989Naperville, IlLed 45-person system architecture team for the 5ESS switch Integrated Services Digital Network (ISDN).Founding member of the Robert Kelley (Carnegie Mellon University) “Star Performer Project” initiated at Bell Labs and later published in the July-August 1993 Harvard Business Review,
Doug Newlin Skills
Doug Newlin Education Details
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Computer Science -
Computer Science, Economics
Frequently Asked Questions about Doug Newlin
What is Doug Newlin's role at the current company?
Doug Newlin's current role is Experienced Consultant / Individual Contributor / Executive Management.
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What is Doug Newlin's direct phone number?
Doug Newlin's direct phone number is (224) 212*****
What schools did Doug Newlin attend?
Doug Newlin attended Northern Illinois University, Northern Illinois University.
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Doug Newlin has interest in Exercise, Home Improvement, Reading, Shooting, Gourmet Cooking, Sports, Golf, Food, Home Decoration, Health.
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Doug Newlin has skills like Medical Devices, Product Development, R&d, Cross Functional Team Leadership, Product Management, Engineering, Manufacturing, Strategy, Fda, Iso 13485, V&v, Software Development.
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