Jon Schell Email & Phone Number

Saint Paul, Mn, Us

Plymouth, Minnesota, Us

Shoreview, Mn, Us

Provide systems engineering and project management consulting services to the Medical Device Industry:• Implementation of Requirements Management System (Jama) and Issue, Defect, and Improvement Tracking (Jira)• Requirements definition, standards assessment, risk management, baseline control for neurostimulation patient trialing system including Issue Resolution and Verification with External Sub-System suppliers• Project Management: Technical Planning, Technical Effort Assessment, Verification and Validation, and Product Release • Translation of a human feasibility research system to customer requirements, system requirements, architecture definition, for an acute use diagnostic system• Technical Assessment and Competitive Analysis for multiple market segments including Atrial Fibrillation, Pulmonary Health, and Ablative Therapies• Development of Predictive Reliability Requirements including Requirements Definition, Risk Management, and Verification and Validation for a chronically implantable neurostimulator system • Negotiation and ownership for Sales, Contract Negotiation, Non-Disclosure, Intellectual Property

Fridley, Minnesota, Us

• Create requirements flow, architecture diagram, flow customer needs to subsystem requirements and test methods for superDimension Illumisite platform• Develop and submit intellectual property for novel electromagnetic sensors, tools, and navigation algorithms• Plan and execute In-Vivo Accuracy of Electromagnetic Navigation Bronchoscopy system (ENB) preclinical studies to achieve Regulatory approval• Publish abstracts with posters regarding preclinical testing of novel lung tools at ATS 2015• Plan, schedule, coordinate and execute Physician Feedback sessions with ex-vivo bench model and in-vivo preclinical model • Assess competitive ENB technologies via bench testing and simulated use, Provide feedback and comparison to Sales and Marketing

Minneapolis, Mn, Us

Chief Engineer for Sub-Cutaneous ICD project including overall technical leadership for a team of 29 and a budget of $85 million. In parallel help CRDM management develop overall system architecture roadmap for 5-year plan.

Technical Lead and Core Team Member for mechanical development and lead for subcutaneous defibrillator (Sub-Q ICD) advanced development team. Extensive pre-clinical and clinical research on concepts for implant technique, fixation, lead energy delivery, and device placement while qualifying an acute human research system. In parallel, Technical Advisory Committee Member for Micra Leadless Pacemaker and Reveal Linq implantable loop recorder.

Minneapolis, Mn, Us

Lead Design Engineer for Attain Performa quadripolar family of Cardiac Resynchronization Therapy (CRT) platform. Led team of 12 engineers in developing three models on a common platform using Lean Product Development and Design for Reliability and Manufacturability (DRM) principles. Oversaw process from concept initiation to clinical studies and transfer to high volume manufacturing. Provide statistical analysis and modeling projections for Fidelis family of high voltage leads. Winner of CRDM and Corporate Star of Excellence, CRDM Customer Focus Norm Award.

Design engineer in startup environment for Sleuth and Sleuth AF implantable loop recorder that received FDA approval. Responsibility included generating IP, design documentation, sourcing and qualifying components from suppliers, verification, and validation.

Advanced Manufacturing developing 3 critical processes for COGNIS/TELIGEN first generation lithium ion primary cell for implantable medical product. Technical lead for second generation primary cell including generating Intellectual Property, Design Documentation, leading team meetings, coordinating builds, and providing management with schedule updates.

One of two engineers pioneering the use of digital twins for new product development including design verification and process development. Utilized non-linear finite element analysis with statistical methods to shorten development times and increase test success by simulating in-vivo use conditions for comparison with verification test methods. Improved yields by modeling complex non-linear manufacturing processes and recommending improvements. Presented technical papers at external conferences describing method development.

Engineering support of new and market release products including transferring the Intermedics FINELINE/ThinLine family of leads to high volume manufacturing site and incorporating yield enhancements. Perform root cause analysis of field clinical returns, trend analysis and reporting, and design enhancements of market released products.

Madison, Wi, Us

Dearborn, Michigan, Us

Arlington, Va, Us

Mba, Entrepreneurship/Entrepreneurial Studies

Ms, Mechanical Engr

Bachelor Of Engineering (Beng), Mechanical Engineering