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.
• 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.

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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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..
• 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.
• 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