Mark A. MacGregor 651-269-9379 macgregormark@yahoo.com
141 Belvidere Street East, Saint Paul, MN 55107
Personal Profile:
Medical device product developer and innovator, recognized for bridging mechanical, electrical, and physiological
domains. Unique multidisciplinary background in R&D, Clinical, Manufacturing and Quality, from concept through
commercialization. Systems thinker, project manager, and cross functional leader, known to leverage scientific
with humanistic principles to meet stakeholder needs. Creative solutions regularly born out of careful observation
of systems and a holistic approach that is genuinely concerned for people and how they think.
Education: Bachelor of Science, Mechanical Engineering, UW-Madison, May 1988
MSME, Industrial & Systems Engineering Minor, UM-Twin Cities, December 2011
Community: Served on Board of Directors for Great River School, creating Community Voices program. Provided
technical input and mentorship on MIT InvenTeams project: wind turbine site evaluation system.
Honors: Twice awarded Medtronic’s Star of Excellence for developing a process validation system and for
commercializing the Deep Brain Stimulation Lead.
Skills: Lean Six-Sigma certified, Minitab, ANSYS/CFX, SolidWorks, Human Factors, TRIZ, FMEA, QFD, SPC, DOE, GR&R.
Work Experience:
Topera Medical (December 2010–Present)
VP Systems Engineering
Systems-level development and clinical support for arrhythmia localization product involving
software, hardware, and catheter. Led core team, created Product Dev. Process, Project Plan,
Risk Assessment, and Systems Requirements (QFD), contributed to 510K and FDA clearance.
St. Jude Medical (2002–2010)
Principal R&D Engineer (September 2008—2010)
Invented new patch technology to improve accuracy of NavX and facilitate new cardiac mapping catheter system.
Led first pre-clinical study comparing NavX accuracy across multiple hardware configurations.
Characterized accuracy versus patient, catheter electrode, patch, connection and amplifier
impedances; wrote associated design specifications.
Organized and led pre-clinical studies; performed data analysis and published scientific reports.
Modeled overall electrical circuit to quantify and address sources of error.
Invented Electrode Impedance Compensation to manage electrode variation.
Improved electrodes using electrochemical impedance spectroscopy (EIS).
Principal Engineer (2002—September 2008)
Appointed as R&D representative to lead and approve resolutions to catheter issues. Correlated electrode
performance with mapping accuracy of EnSite system and created associated specifications.
Led cross-functional teams to save >$1MM annually.
Invented controlled injection of adhesive through port holes to stop fluid leakage.
Invented forming process to prevent blowout of atraumatic catheter tip.
Created thrombogenicity test chamber to explore heparin reduction in clinical use.
Developed and validated new ETO sterilization processes; qualified new ETO process challenge devices.
Led cross-functional teams in CAPA investigations, health hazard analyses and FMEAs.
Used analytical methods such as EIS, mass spectroscopy, Auger, TOF-SIMS, FTIR, and SEM.
Developed new technology with Quadrupled YAG laser on stainless steel.
Optimized CO2-TEA laser processes using DOEs; improved vendor test methods and controls.
Medtronic (1990–2001)
Engineering Consultant (October 1998—December 2001)
Developed ICD connector block anchoring process, including tooling design and DOE, and
coordinated start-up activities in Puerto Rico.
Developed Muscle Stimulation Lead processes, resolved design issues, led risk assessments and
FMEAs, wrote and performed design verification tests and reports.
Principal Quality Systems Engineer (November 1996—September 1998)
Led over 50 employees on multiple teams in division-wide Quality Systems initiatives.
Created product development procedures under FDA Design Control.
Appointed to corporate CAPA team to resolve product distribution system issues.
Performed failure analysis, leak rate, and risk assessment on drug pump field issue.
Led key aspects of divisional Quality Improvement Team: developed strategies, literature, and rewards.
Conceived of and led implementation of Neuro “Process Assurance System” (process development, risk assessment,
qualification, validation, and change-control), earning the 1998 Star of Excellence.
Senior Development Engineer/Project Manager (September 1993—October 1996)
Led cross-functional teams to develop and commercialize over a dozen stimulation leads and
accessories, including a hybrid electrode catheter and the DBS lead, earning a 1995 Star of
Excellence team award. Presented inventions at annual Medtronic Technology Conference.
Invented vacuum process to post-cure silicone rubber, improving speed, reducing
temperature, and eliminating degradation of PU components.
Designed one piece compression-molded silicone connector, solved polyurethane
deformation issue, and reduced part cost.
Invented tester to impart large amplitude cyclic tension, more appropriate for
neurological leads, improving design qualification and product reliability.
Manufacturing Engineer, MECC (October 1990—August 1993)
Recognized leader in battery and IPG feedthrough process development and improvement.
Invited to deliver oral presentation at annual Medtronic Technology Conference.
Developed Pressure Sensor Feedthrough and associated vacuum furnace brazing cycle.
Doubled glassing furnace capacity, reduced cycle time by 4X, scrap by 6X, and rework by 2X.
Built sampling RGA to analyze glassing furnace headspace, identifying sources of contamination.
Performed DOE to set furnace operating parameters, improving glass meniscus and reducing cracking.
Invented new fixture to minimize outgassing, reducing feedthrough oxidation, cleaning, and glass damage.
UFE Incorporated (July 1988–October 1990)
Manufacturing Engineer, Thermoplastic Injection Molding
Appointed as primary contact for medical customers on production issues.
Improved molding processes, including decoupled approach (RJG-trained).
Designed hot-runner molds employing cavity-pressure feedback.
University of WI, Madison (1984–1988)
Laboratory for Thin Film Deposition
Designed and built high vacuum systems and electronic circuitry for sputtering, ion beam, and electron beam deposition.
Applied leak theory and residual gas analysis; installed and repaired diffusion, ion and turbo vacuum pumps.
Deposited thin films, including multi-layer super-conducting films using feedback-controlled deposition rates.
Mark A. MacGregor 141 Belvidere Street East Saint Paul, MN 55107 651-269-9379 macgregormark@yahoo.com
11-17-2011