Mark Strong Email & Phone Number

Maple Grove, Minnesota, Us

Solving Heart Failure with Preserved Ejection Fraction for Millions of Heart Failure Patientswww.heartfailureinc.com

Minneapolis And St. Paul, Minnesota, Us

Abbott Park, Illinois, Us

Head of Research and Development executing critical programs for the entire Cardiac Arrhythmia and Heart Failure portfolio. Worked cross functionally to create a portfolio of products for each of the three franchises: Cardiac Rhythm Management, Electrophysiology, and Heart Failure. Chaired Project Review Board for monthly portfolio performance review. Managed staff of 1075 worldwide and an annual budget in excess of 240M.• Developed strategic partnerships with key Physician customers from top centers in the world.• Delivered over 14 new commercial product approvals for CRM, EP and HF Franchises.• Lead Intellectual Property Board for oversight of new technology roadmap and planning.• Performed technical diligence on multiple Abbott Business Development investments.• Recruited top talent for critical technology areas of cloud computing, artificial intelligence, machine learning, cybersecurity, software, and PFA.• Member of Abbott’s Scientific Governance Board.Recent Product Approvals:CRM: Flash2, Flash3, Confirm Rx, Gallant, Agilis HIS ProEP: Advisor VL, Tactiflex IDE, LiveView, Ensite X (Europe)HF: HM3 Clip, Heartmate Touch Ipad, Heartmate LIS & Coring Tool

Framingham, Massachusetts, Us

As a company officer reporting to the CEO and board of directors, was responsible for executing on critical corporate milestones for Research, Development and Quality. Worked cross functionally to assemble a comprehensive R&D portfolio to respond to un-met customer needs. Chaired Project Oversight Board (POB) and Technology Development Projects (TDP) for portfolio on a monthly basis. Managed staff of 275 worldwide and annual budget in excess of $88M. • Responsible for delivering all major pump, electronics and implantable programs on time including Pioneer SMR, Pioneer 2.0, Destination Therapy, and Commercial PAL Controller.• Performed due diligence on 5 companies over the last 2 years including Mechanical Circulatory Support (MCS) and Mitral / Tricuspid Valve innovation space. Participated in negotiations and integration planning for accepted offers.• Led the restructure of the Heartware quality organization in response to the 2014 warning letter. Initiated 7 Corporate Quality Plan work streams to remediate major observations: Design Controls, CAPA, Complaints, Field Safety Corrective Action, Risk Management, Purchasing Controls and Non-Product Software. Facilitated discussions with the FDA to ensure alignment of the remediation plan. Provided weekly updates to CEO on progress of remediation. Completed & executed plan for the organization for re-inspection in the fall of 2016.

Framingham, Massachusetts, Us

Led major Heartware R&D programs to improve the quality of patient care through commercial and clinical trial introductions for Mechanical Circulatory Support (MCS) platforms. Managed staff of 120 full-time employees and 50 contract employees worldwide and annual budget in excess of $70M.• Led entire company through the completion of the MVAD Pump and Controller PDP in preparation for first ever clinical trial of the new left ventricular support platform (MVAD). Facilitated cross company collaboration to ensure design, verification, validation, regulatory / clinical submission and manufacturing of commercial and new products under development. Completed submission within 15 months of accepting the position and implanted first device within 21 months• Fostered an environment that encouraged early stage technology innovation that fed new commercial development platforms. Moved critical pump platforms and implantable platforms ahead in their tech development to close critical knowledge gaps.• Accelerated product development by facilitating the implementation of major corporate initiatives related to product quality, lean design controls process, offshore software development through use of a global work force.

Marlborough, Ma, Us

Led major CRV R&D programs to improve the quality of patient care through innovative remote patient monitoring, patient follow up, point of care devices, iPhone apps, implantable & external sensors and heart failure management. Facilitated the implementation of major corporate and divisional initiatives related to product quality, lean design process, offshore manufacturing and software development through use of a global work force. Provided design services to other BSC divisions. Fostered an environment that encouraged early stage innovation that fed product development cycle. Managed staff of 325 worldwide and annual budget in excess of $56M. • Delivered greater than 15% Value Improvement Program savings in 2012, resulting in R&D savings of over $7.6M. On track for similar result in 2013.• Achieved 30% product development cycle time reduction through utilization of research and design resources in Minnesota, California, India and China creating and manufacturing on-time high quality Class 3 Medical Devices. • Delivered 7 key programs in 2 years achieving greater than 95% of program milestones. Programs delivered included Latitude NXT Remote patient monitoring system released Feb. 2013 which was rapidly adopted by the marketplace. Programs submitted included Ingenio MRI Pacemaker. • Facilitated innovation workshops utilizing Stanford Bio-Design techniques that generated 50 ideas leading to multiple patents.

Marlborough, Ma, Us

Responsible for the creation of product requirements, design and specifications for CRM products and for management of the Product Development Life Cycle Process and regulatory design controls. Ensured final product requirements and specifications were validated and verified to user needs and product requirements & specifications. Managed staff of 150 individuals and annual budget in excess of $25M.• Delivered new pacemaker and defibrillator lines to refresh the portfolio.• Transformed dysfunctional design organization into high-performing team by re-vamping infrastructure, improving processes and engaging staff, leading to enhanced quality, speed and value. • Introduced and implemented strategic planning process Cardiac Rhythm Management (CRM) Systems and Design Engineering Groups and aligned and engaged teams to deliver to plan. • Led innovation consortium which led to presentation of 5 top ideas to Technical Product Investment Board.

Marlborough, Ma, Us

Responsible for direction and work product of 9 major support staff areas in the corporate design services organization: Integrated Circuit Design and Hybrid Design Engineering, Engineering Compliance Organization, RF Management and Licensing, Application Engineering Group & Mechanical Design, Electrical and Mechanical Design Labs, PG Program Management, Leads Program Management, Design for Six Sigma and Literature & Labeling. Owner and maintainer of CRM product development life cycle. Staff included over 100 individuals; annual budget was over $20M. • Facilitated effort to expand new product lines into key international geographies (including high growth BRIC countries) driving over 30% increase in sales revenue upon release.• Delivered smallest thinnest defibrillator / heart failure device to increase implantable sales.• Introduced and deployed Six Sigma program for all of R&D resulting in first year savings of $2M and establishment of Six Sigma culture.

Led and facilitated work direction for Processing group, Device Analysis & Characterization Group and Reliability Engineering Department. Corporate quality leader for Guidant product advisory activities: interfaced with legal, compliance, regulatory, marketing, manufacturing, supplier development, product engineering, product performance, tech services, event analysis, outside law firms, regulatory agencies, outside panels, J&J and BSX. Staff included over 30 individuals; annual budget was over $12 M.• Increased efficacy and efficiency of device root cause analysis to greater than 90% as well as improved overall workflow process. • Managed a diverse team of engineers, technicians, and production staff through a corporate crisis.

Collaborated with New Product Planning to conceptualize new products. Led working teams to convert new concepts into initial project contracts. Gained cross functional alignment for the program & associated risks. Created & managed schedule for entire project. Managed staff of 25 and annual budget of over $8M. • Managed design and implementation of a new hardware platform. Completed first of its kind Radio Frequency Implantable Cardiac Defibrillator within 18 months on a $13M dollar budget.• Completed a critical portion of the Integrated circuit design through a remote design facility in Redmond, Washington.

Managed early prototype / pilot builds on the line and served as the interface between the design team. Group served a critical role ensuring that the team met their critical milestone delivery on schedule. Diverse group numbered over 20 individuals; annual budget was over $6 Million.• Recruited and developed top Electrical Engineering talent to drive world class products.• Put in place project management methods to ensure on time delivery to the design team.

Mba, Business

Msee, Semiconductor Design

Bsee, Electrical And Electronics Engineering