Michael Paradis Email & Phone Number

Saint Paul, Mn, Us

Minneapolis, Minnesota, Us

Lenexa, Kansas, Us

Vantage MedTech provides comprehensive design & manufacturing services, accelerating the development of medical technologies from concept to product realization. Specializing in RF, PEF, Microwave Ablation Generators & associated capital equipment, Vantage partners with the world’s most innovative MedTech start-ups & OEMs by offering strategic support at every phase of the product development lifecycle.𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲:● Manage New Product Development (NPD) Programs with durations of 6-24 months including Planning, Design, DV & Manufacturing Design Transfer phases● Successfully lead multidisciplinary technical teams (Systems, Electrical, Mechanical, Embedded SW Dev, Test, Cybersecurity, Process Dev & Mfg) through full Product Development Process● Manage competing project constraints including scope, schedule, budget, resource allocation, technical risk & quality● Drive strategic project execution & manage contract scope changes with rigor, ensuring program profitability● Build collaborative internal team dynamic and strong client relationships, enabling collective success in assigned NPD programs𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗔𝘀𝘀𝗶𝗴𝗻𝗺𝗲𝗻𝘁𝘀:● Agile SW & HW Dev of Abiomed's Next Gen preCARDIA system for patients with Acute Decompensated Heart Failure (ADHF)● DHF, DV, & successful 510(k) clearance of NeuroOne's RF Generator, indicated for creation of RF lesions in nervous tissue for functional neurosurgical procedures● HW & SW Update & various FiH System Builds for Zidan Medical's Endobronchial RF Ablation Generators● Commerical SW Update, System Integration, DV & Design Transfer of Neurent Medical's NEUROMARK RF Generator, designed to eliminate symptoms of chronic rhinitis● CE Mark Technical File Support for MDR Submission of May Health's RF Generator

Marlborough, Ma, Us

Responsible for supporting the redesign of the EkoSonic™ device's piezoelectric transducer elements as well as the development of full system Design Verification (Durability and Reliability) testing.Boston Scientific's EKOS™ Endovascular System was the first interventional ultrasound-assisted thrombolysis catheter indicated for the treatment of Pulmonary Embolism (PE). Also used for treatment of Deep Vein Thrombosis (DVT) and Peripheral Arterial Occlusion (PAO), EKOS™ is designed for the infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The device's ultrasound therapy system accelerates drug dispersion, requiring less lytic agent to dissolve thrombus.

Brooklyn Park, Minnesota, Us

Switchback Medical offers a single-source solution for medical device design, process development and contract manufacturing, simplifying your supply chain, cutting development costs and decreasing overall time to market.𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Occlusion Balloon Guide Sheath and Delivery System R&D/ Operations Tech Lead● Custom Coil Winder Equipment/ Fixturing Development and Process Validation (IQ, OQ, PQ)● Cardiovascular Occluder Implantable Device Delivery System Design Verification (DV) Testing● Radio Frequency (RF) Tipping Process Development ● Rapid Prototyping/ Assembly Fixture Development● Project Management and Engineering Leadership Support

Minneapolis, Mn, Us

While working in Medtronic's Aortic, Peripheral & Venous (APV) division I supported the research, design and manufacture of the world's first and only Class III permanently implantable vascular plug deliverable through a microcatheter, the MVP™ Microvascular Plug.𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Multi-national design ownership & manufacturing site transfer tech lead for commercial products post-acquisition● Development and Controlled Release of entire set of Design Drawings, Bill of Materials and associated Design Control Documentation● Flow Occlusion, Deployment & Retraction, Membrane Bond Tensile Strength, Particulate Release and Radial Force Test Method Development (DoE), Equipment HW & SW Specs, Calibration, Installation Qualification, Technician Training, Test Method Validation, and Statistical Analysis● Development of Customer Product Requirements (CPRD) Documentation● Technical and Business Risk Assessments (dFMECA, pFMECA)"Today, interventional radiology is a field being driven forward by advances in embolization. Embolization continues to evolve into an effective treatment for benign and malignant tumors, traumatic vascular injury, vascular malformations, and countless other potential indications... advantages of [the MVP™] device include its compatibility with existing microcatheters, deliverability through potentially tortuous anatomy, and ability to be resheathed and repositioned before deployment, if needed." (https://evtoday.com/articles/2016-apr/the-mvp-microvascular-plug)While working in Medtronic's APV division, I was also exposed to the development and manufacturing of a comprehensive line of products to treat Aortic and Peripheral Vascular disease, including: ● Endovascular Stent Graft Systems ● Peripheral Drug Coated Balloons and Stents ● Angioplasty and Embolization Products ● Carotid Embolic Protection Devices [https://www.medtronic.com/us-en/patients/treatments-therapies.html]

Marlborough, Ma, Us

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Functioned as operations and manufacturing engineering support for BSCI’s AMS Ambicor™ and Spectra™ Implantable Device Assembly Lines.● Led the design of custom Saline Water Deaeration Equipment, including the development of User Requirements Specifications (URS), Functional Specifications (FS) and Equipment Hazard Analyes (EHA) for system hardware and software.● Supported the Redesign of Vacuum Generators for Foreign Material and Excess Adhesive Removal during product assembly in BSCI’s Controlled Manufacturing Environment.● Drove continuous improvement initiatives through revisions to various Assembly Work Instructions, Installation Qualification (IQ) Protocols, Equipment Specs, Preventive and Corrective Maintenance Requirements within a strictly controlled Medical Device Manufacturing Clean Room.● Performed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for various pieces of manufacturing equipment including replacement Convection Ovens and custom built assembly fixtures.

Abbott Park, Illinois, Us

Member of Legacy St. Jude Medical Structural Heart R&D Division.Departmental Objective: To restore and improve quality of life through the design of device and management solutions for the treatment of structural heart disease.http://www.abbott.com/consumer/cardiovascular.html𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Coordinated product research on Vascular Plugs, and delivery systems. (Included work on nitinol thermomechanical properties, in-vivo fluoro image analysis and assistance with FEA Modeling).● Developed test equipment, work instructions & R&D reports for statistical analysis of vascular embolization implantable devices within simulated peripheral vasculature.● Conducted biocompatibility and mechanical properties research comparing various nitinol surface finishes for a diverse set of Class III medical devices. ● Led statistical analysis of structural heart occluder radial force testing under various rates of compression/ relaxation, temperature conditions, & lag times.● Participated in various cross-functional projects relating to obsolescence planning (product rationalization), supplier change control & Abbott re-branding.● Worked on the strategic redesign of delivery cables in an effort to develop BOM cost reductions.● Performed extensive design research & competitive market analysis on global guide wire product portfolio in support of regulatory requirements.

Memphis, Tn, Us

Wright Medical Group, Inc. engages in the design, manufacture, and distribution of biologic products. It provides surgical solutions for the foot and ankle market and its products include large joint implants for the hip and knee, extremity implants for the shoulder, elbow, hand, wrist and foot and biologic products, including bone graft substitutes.𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Assisted in the advancement of Wright Medical's FDA (as well as BSI - European regulatory body) compliance systems for the Biological Evaluation of Medical Devices (per ISO 10993). ● Redefined standardized techniques for Wright's global supply chain data collection processes. (Lead Engineer for project consisting of controlled documentation of more than 20 independent Suppliers' multi-level BOMs and their associated critical manufacturing contaminants, safety data sheets and process validation reports).● Conducted large-scale remediation of internal Biocompatibility Reference Documentation for ongoing Chemical Characterization Testing (Solvent-Based Chemical Extraction) and Toxicological Risk Assessments.● Developed Corporate Standard Operating Procedures, Work Instructions, and Engineering Change Notices as well as many other med-device manufacturing technical reports.● Participated in Advanced Geometric Dimensioning & Tolerancing (GD&T) Corporate Training Program as well as several Corporate events including Productivity Quality, Inc.'s touch probe metrology, CT and Laser Scanning services conference.

Edina, Mn, Us

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Collaborated with design engineers, corporate buyers, business account managers, suppliers and quality assurance personal in developing die-cut, waterjet, laser-cut, 3D printed, injection molded, and extruded machine components, measurement fixtures and production tools.● Advanced company's technical expertise in core technologies (Sound & Vibration, Adhesives, Gaskets, EM/RF Interference & Thermal Management) through materials research, testing and client presentations. ● Managed the design, materials selection, pricing, manufacturing workflow, and quality inspection operations for rapid prototyping, new production part and legacy part programs.● Designed educational seminars, official statements of work, process capability (Cpk/Ppk) studies, custom testing protocols, production part approval processes (PPAPs) & other technical documents for internal and external customers.● Represented PGC in various collaborative projects with Fortune 100 OEM clients and industry trade shows including: Design 2 Part and Minneapolis Medical Device & Manufacturing (MD&M).● Participated in numerous supplier educational presentations & facility tours including: The QC Group's GD&T Training, 3M's Advanced Converter College (Level 1 & 2), Interface Sealing Solutions'​ and Thermoseal's Gasketing Theory, Lauren Manufacturing's Rubber Compounding and Extrusion Course, 2014 Gasket Fabricators Association Conference Informational Sessions.● Led National S.T.E.M. Education Initiative: "Project Lead the Way"​ Engineering Internships with Edina Public Schools students.(https://web.archive.org/web/20150712010946/http://edinamag.com/engineering-future)● Designed and implemented PGC's new GC-Series Dynamic Sealing Materials Product Line Webpage. (https://pgc-solutions.com/solutions/engineering/gc-series-materials/)

Bloomington, Mn, Us

𝗥𝗲𝘀𝗽𝗼𝗻𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝗶𝗲𝘀 𝗜𝗻𝗰𝗹𝘂𝗱𝗲𝗱:● Fabricated various prototype filtration systems testing fixtures● Coordinated ISO 5011 standardized test methods for Donaldson's QA, R&D and Production Divisions● Prepared various filter performance tests (filter restriction, differential pressure & contaminant extraction efficiency) for analysis and product development teams(https://www.donaldson.com/en-us/engine/filters/products/air-intake/)● Participated in continuous improvement projects to increase lab efficiency

Maple Plain, Mn, Us

Assisted with the development of Metal Injection Molding (MIM) systems: ● SolidWorks 3D CAD Training● Operated Electric Injection Molding Press for MIM Development● Lead Statistical Research of MIM Part Dimensional/ Density Variations (Gas Pycnometry)● Primary Researcher of Debinding & Sintering Operations

Charlotte, North Carolina, Us

● Administered test procedures for thermostat control modules.● Assisted with the development of energy conservation thermostat control algorithms. (http://www.homesecurity.honeywell.com/energy_management.html#thermostat)● Involved in extensive multinational collaboration on redesign of motorized air duct zoning actuators. (https://www.youtube.com/watch?v=-TE1Vc2oU8c)● Designed and constructed environmental test chambers and fixtures for comparative analyses of prototype and baseline residential HVAC systems.● Supported the development of prototype thermostat circuit boards as well as stunt/programming boards.

Master Of Science - Ms, Managment Of Technology (Mot)

Bachelor'S Degree, Physics & Math - Double Major