Mark Macgregor

Mark Macgregor Email and Phone Number

Systems thinker with pragmatic, continuous improvement orientation and Six-Sigma-certification. @ Francis Medical
Mark Macgregor's Location
St Paul, Minnesota, United States, United States
Mark Macgregor's Contact Details

Mark Macgregor work email

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About Mark Macgregor

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.

Mark Macgregor's Current Company Details
Francis Medical

Francis Medical

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Systems thinker with pragmatic, continuous improvement orientation and Six-Sigma-certification.
Mark Macgregor Work Experience Details
  • Francis Medical
    Principal Design Assurance Engineer
    Francis Medical Sep 2021 - Present
    Maple 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
  • Imris, Deerfield Imaging
    Principal Systems Engineer
    Imris, Deerfield Imaging Oct 2020 - Sep 2021
    Chaska, Mn, Us
    • Redesign of neurosurgical stabilizer device attachment to bed• Systems requirements management• Site responsibility for EO sterilization
  • Bsi
    Technical Specialist, Regulatory Services
    Bsi 2019 - 2020
    London, 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
  • Abbott
    Engineering Consultant (St Jude Medical)
    Abbott 2017 - 2019
    Abbott Park, Illinois, Us
    Test 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
  • Start-Ups (Full-Time) And Contracts
    Various Positions
    Start-Ups (Full-Time) And Contracts 2010 - 2017
    Sr 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
  • St. Jude Medical (Endocardial Solutions)
    Principal Engineer
    St. Jude Medical (Endocardial Solutions) 2002 - 2010
    R&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
  • Medtronic
    Engineering Consultant
    Medtronic 1998 - 2001
    Minneapolis, Mn, Us
    Muscle Stimulation Lead and ICD connector block processes. Reliability Engineering support, risk assessments and FMEAs on Graciloplasty and Functional Stim Leads.
  • Medtronic
    Principal Quality Systems Engineer
    Medtronic 1996 - 1998
    Minneapolis, Mn, Us
    Division-wide Quality Systems initiatives and leadership of 50+ employees on multiple teams. Medtronic Star of Excellence for Neuro process validation system.
  • Medtronic
    Senior Development Engineer/Project Manager
    Medtronic 1993 - 1996
    Minneapolis, Mn, Us
    Cross-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.
  • Medtronic
    Manufacturing Engineer
    Medtronic 1990 - 1993
    Minneapolis, Mn, Us
    Battery and IPG feedthrough manufacturing process development and CI. Oral presentation at annual Medtronic Technology Conference.
  • Ufe
    Manufacturing Engineer
    Ufe 1988 - 1990
    Us
    Injection molding processes (RJG-trained), tooling, and test methods. Technical leader for medical customers and related production issues.
  • University Of Wisconsin-Madison
    Laboratory For Thin Film Deposition
    University Of Wisconsin-Madison 1984 - 1988
    Madison, Wi, Us
    Equipment installation and thin film deposition for Surface Science program.

Mark Macgregor Skills

R&d Statistical Data Analysis Minitab Systems Engineering Testing V&v Product Design Process Improvement Medical Devices Fmea Design Control Dmaic Designs Catheters Six Sigma Quality System Fda Iso 13485 Iso 14971 Commercialization Spc Lean Manufacturing Design For Manufacturing Injection Molding Design Of Experiments Biomedical Engineering Process Simulation Validation Project Management Human Factors Qfd Triz Pre Clinical Studies Process Engineering Technical Writing Capa Product Development Drug Delivery Root Cause Analysis Supplier Quality Failure Analysis Cross Functional Team Leadership Design For Six Sigma Ansys/cfx Wire Braiding Leak Testing Eo Sterilization High Vacuum Technology Electrode Impedance Testing Manufacturing Data Analysis Comsol Technical Leadership

Mark Macgregor Education Details

  • University Of Minnesota
    University Of Minnesota
    Industrial & Systems Eng Minor
  • University Of Wisconsin-Madison
    University Of Wisconsin-Madison
    Mechanical 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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