Mark Macgregor Email and Phone Number
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Systems thinker with pragmatic, continuous improvement orientation and Six-Sigma-certification, twice awarded Medtronic’s Star of Excellence, experienced in Product Development and R&D, Design Assurance and Quality Systems, Pre-clinical, and Manufacturing on Class II & III medical devices and drug delivery devices. Curiosity and desire to understand complex systems and processes at a fundamental level, including clinically realistic specifications and test methods. Cross-disciplinary skills bridging mechanical, electrical, and electro-chemical principles and applications.
Francis Medical
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Principal Design Assurance EngineerFrancis Medical Sep 2021 - PresentMaple Grove, Minnesota, Us• Electromagnetic Navigation: CAPAs, accuracy and TM improvements• Stabilizer arm specs, DOE and design improvements for next gen product• FMEAs, Hazard Analysis, Risk Management (RM) Report and SOPs• RM system reconfiguration (P1 x P2 methodology)• Quality Engineering support such as ECOs, IQ, OQ, validation -
Principal Systems EngineerImris, Deerfield Imaging Oct 2020 - Sep 2021Chaska, Mn, Us• Redesign of neurosurgical stabilizer device attachment to bed• Systems requirements management• Site responsibility for EO sterilization -
Technical Specialist, Regulatory ServicesBsi 2019 - 2020London, Gb• Technical reviews for CE Mark (MDD/MDR) on Vascular Devices team• Focus areas: design validation, clinical use studies, risk management• Wires, atrial clip, EP, FFR, IVUS re-entry, dialysis, molding-balloon catheters -
Engineering Consultant (St Jude Medical)Abbott 2017 - 2019Abbott Park, Illinois, UsTest method R&D leadership for the EnSite EP Cardiac Mapping System• First-ever design of human-like impedance environment in a saline tank• Electric field simulations (COMSOL) of clinical use in bench test design• Statistical analysis of electric fields, direction, gradient (human database)• Human factors analysis to identify need for shape accuracy• Displayed vs. actual cardiac shape accuracy via centroid contour distance• Shape correlation test method using CT scans of cardiac anatomy -
Various PositionsStart-Ups (Full-Time) And Contracts 2010 - 2017Sr Pr Engineer, St. Teresa Medical – Dissolvable electrospun hemostatic dressingEng Consultant, Phillips-Medisize – Epoxy bonding process and joint design for eye implantEng Consultant, Amgen – Resolution of FDA 483 usability issues on pre-filled drug syringes Sr Pr Systems Engineer, Acutus Medical – Biopotential and localization systems in EP mapping Eng Consultant, SurModics – Optimization of drug transfer from PTA balloon catheters to arteriesVP Systems Engineering, Topera – Arrhythmia localization software and EP mapping system
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Principal EngineerSt. Jude Medical (Endocardial Solutions) 2002 - 2010R&D, manufacturing, and blackbelt CI leadership on EnSite Array, next generation EP non-contact mapping catheter, and EnSite cardiac mapping systems• Navigation accuracy: first pre-clinical study across hardware generations• Electrical model creation and pinpointing of error sources: electrodes, patches, amplifier input impedances, patient inhomogeneity• Bifurcated surface patch: invention to improve NavX accuracy (patent)• CO2-TEA laser processes: electrode impedance variability reduction (DOEs), correlation to improve EnSite mapping accuracy• Electrode impedance, laser and wire braiding test methods, controls, specs (e.g. frequency roll-off, laser power, wire curl)• $1MM/yr savings, 6-Sigma projects: Greenbelt-certified, Blackbelt-trained• Leak thru adhesive bond to stainless steel: pressure decay testing, clinical spec; novel adhesive injection to maximize bond length• ETO sterilization: validation of new process challenge device; cycle parameter improvements; ETO residual reduction• Analytical methods: electrochemical impedance spectroscopy (EIS), mass spectroscopy, Auger, TOF-SIMS, FTIR, SEM, and cross-sectioning• Six-sigma Green Belt certified, Black Belt trained
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Engineering ConsultantMedtronic 1998 - 2001Minneapolis, Mn, UsMuscle Stimulation Lead and ICD connector block processes. Reliability Engineering support, risk assessments and FMEAs on Graciloplasty and Functional Stim Leads. -
Principal Quality Systems EngineerMedtronic 1996 - 1998Minneapolis, Mn, UsDivision-wide Quality Systems initiatives and leadership of 50+ employees on multiple teams. Medtronic Star of Excellence for Neuro process validation system. -
Senior Development Engineer/Project ManagerMedtronic 1993 - 1996Minneapolis, Mn, UsCross-functional team leadership, development, and commercialization of over a dozen stimulation leads and accessories, including a hybrid lead-catheter and the DBS lead, earning Medtronic Star of Excellence. -
Manufacturing EngineerMedtronic 1990 - 1993Minneapolis, Mn, UsBattery and IPG feedthrough manufacturing process development and CI. Oral presentation at annual Medtronic Technology Conference. -
Manufacturing EngineerUfe 1988 - 1990UsInjection molding processes (RJG-trained), tooling, and test methods. Technical leader for medical customers and related production issues. -
Laboratory For Thin Film DepositionUniversity Of Wisconsin-Madison 1984 - 1988Madison, Wi, UsEquipment installation and thin film deposition for Surface Science program.
Mark Macgregor Skills
Mark Macgregor Education Details
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University Of MinnesotaIndustrial & Systems Eng Minor -
University Of Wisconsin-MadisonMechanical Engineering
Frequently Asked Questions about Mark Macgregor
What company does Mark Macgregor work for?
Mark Macgregor works for Francis Medical
What is Mark Macgregor's role at the current company?
Mark Macgregor's current role is Systems thinker with pragmatic, continuous improvement orientation and Six-Sigma-certification..
What is Mark Macgregor's email address?
Mark Macgregor's email address is mm****@****ris.com
What is Mark Macgregor's direct phone number?
Mark Macgregor's direct phone number is +165126*****
What schools did Mark Macgregor attend?
Mark Macgregor attended University Of Minnesota, University Of Wisconsin-Madison.
What skills is Mark Macgregor known for?
Mark Macgregor has skills like R&d, Statistical Data Analysis, Minitab, Systems Engineering, Testing, V&v, Product Design, Process Improvement, Medical Devices, Fmea, Design Control, Dmaic.
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