Doug Newlin Email & Phone Number

Deerfield, Wi

New 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.

Lake Forest, Il

Oversaw 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.

Elyria, Ohio

Led 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.

Lake Zurich, Il

Oversaw 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.

Round Lake, Il

Led 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).

Rolling Meadows, Il

Launched company’s first voice over IP (VoIP) DOCSIS cable modem ahead of schedule and under budget.

Schaumburg, Il

Product 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.

Naperville, Il

Led 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,

M.S., Computer Science

B.S., Computer Science, Economics