1. Mark S. Curtis
page 1 of 3
Mark.curtis@sbcglobal.net
Summary Degreed Engineer with 30+ years in Medical Device Manufacturing and FDA regulated business.
Experience with low volume implantable device manufacturing, and high volume plastic consumables
lines.
Certified Validation Engineer. Former CAPA team leader. Knowledge of FDA requirements, and
statistical methods such as Cpk, SPC, and DOE to optimize process output, minimize manufacturing
variability, and improve overall product quality.
Completed Process Validations for: Silicone molding; Passivation and Cleaning of Titanium; Laser
Welder;LaserEngraving;LaserStripping;PlasmaEtching.Designedandbuiltseverallargeautomated
systems: Laser Welder for pacemaker enclosure, Pacemaker Lead coil winding system.
Education MSME Southern Methodist University, 1985
BSME University of Maryland, 1979
Work Experience
Medtronic Minimed Northridge, CA (Medtronic acquired MRG and Minimed in 2002) 13+ yrs.
Sr Product Engineer July 2008 - Current Consumables Product Support
 CAPA lead engineer, responsible for documenting and closing CAPA’s. Familiar with TrackWise
software used to track CAPA projects.
 Trend analysis of complaint data from 24hr Help Line for Consumables Operations and CAPA’s.
 Active involvement in product issues
 Supported consumables reservoir production line move to Puerto Rico . Provide engineering support
on equipment issues and trouble shooting.
 Ongoing engineering responsibility for ECO’s between Northridge and PR. Facilitate obtaining
approvals among Regulatory, Quality, R&D, and Reliability departments.
 Technical lead on installation/startup of two Connector Assembly Machines (CAM) at OEM supplier.
Each machine capable of building 6,000 assemblies per hour.
 Review and approve supplier’s injection mold qualifications, and Product qualification of injection
molds.
 Change Control Board and Material Review Board representative for Operations group.
Sr. Mfg. Engineer Nov 2004 - July 2008 Consumables Assy Line
 Responsible for maintaining clean-room with 8 fully automated assembly machines to meet production
demand of 600k reservoirs and infusion set connecters per week.
 Medtronic 2006 Star of Excellence team award for manufacturing reject reduction and cost savings.
Sr. Mfg. Engineer June 2002 - Nov 2004 Implantable Insulin Pump Mfg.
 Revalidation of resistance-welding of the battery lead attachment to hybrid circuit.
 Completed validation of Nitric Acid passivation and Chem cleaning equipment
 Revalidation of implantable pump silicone molding line. Research, purchase, and validate an improved
silicone rubber gum stock roll mill.
Medical Research Group Sylmar, CA Implantable Insulin Pump mfg.
Sr. Mfg. Engineer July 2001 – June 2002 (when Medtronic acquired Minimed & MRG)
 Perform 95/95 analysis on laser weld validations to demonstrate use of statistics in validations.
 Investigation on prevention of micro-cracks in laser welds of Titanium alloys.
 Purchased new laser marking, plasma etching and projection welding systems.

2. Mark S. Curtis
page 2 of 3
Mark.curtis@sbcglobal.net
Guidant Inc, St. Paul, MN (Acquired Sulzermeica’s Pacemaker business in 1998-99) ~2 yrs.
Principal Mfg Engineer Oct 1999 – July 2001 Pacemaker Hybrid Electronics.
 Accepted a transfer to St. Paul after Guidant closed Angleton facility. Stayed in Texas to facilitate
sale of surplus manufacturing equipment.
 Implement and validate IC coating process for pacemaker Hybrid; Parker jet-dispenser.
 Developed intranet web page to track project status using active server pages and MS SQL Database.
 Research 2D Bar-code marking systems and readers for automating product traceability.
 Created prototype E-Signature for web based machine setup parameter card. Used MD5 hash, RC4
encryption, and public-private key technology.
Sulzermedica, Angleton, TX (Intermedics Inc., before Sulzer purchased Co. ) 14 yrs.
Engineering Specialist II 1997 – 1999 Heart Pacemaker mfg.
 Provided technical assistance on the acceptance and validation of an Excimer Laser system for
Parylene removal around edges of pacemaker titanium clamshell for electrical contact.
 Assisted Quality department with implementation of network SPC package and database configuration
setup.
 Key member of team that developed in-house training program for FDA Process Validation.
Sr. Manufacturing Engineer 1994 – 1997
 Supervised staff of 2 Engineers, a Tech Writer, and 2 Technicians.
 Resolved GMP Audit problems. Supervised review and update of all Pacer Area procedures.
Provided feedback to management on Process Validation Global document.
 Completed process Validation cleanup. Principle team member on validation protocol & report format
to successfully revalidate 34 processes.
 Evaluated and solved a critical field complaint using statistical analysis to determine cause. Designed
experiment and supervised staff's’ tests to revalidate mold and process changes.
Sr. Process Engineer 1991 – 1994
 Obtained funding of $120k for new engraving system. Supervised installation and setup.
 Team leader for planning move of laser equipment to new facility. Wrote protocols and revalidated
equipment after relocation into new building.
 Evaluated, selected, and purchased $65k plasma etching equipment with liquid cooled shelves to
shorten Parylene etch times from 14 to 8 hours.
Process Engineer III 1985 – 1991
 Proposed and obtained $316,000 funding for, designed, purchased, and supervised construction of in-
house Laser Welding system. Completed project under budget. Improved production throughput 2.4x.
Used statistical methods to improve process and increase yields. Created over 60 CAD drawings to
thoroughly document its design.
 Designed and built automated pacemaker lead coil winder. Worked on various lead coil winding
processes to evaluate new types of wire and insulation properties.
Texas Instruments Inc. Dallas, TX Military Electro-Optics Group 6 yrs.
Mechanical Engineer 1979 – 1985 Thermal Focal Plane Sensor
 Completed MS in Mechanical Engineering (focus on structural analysis and FEA).
 For a 2D thermal detector, created a 3D FE computer model using SPICE electrical analysis software.
Computer model used by systems engineers to determine detector and system performance. Model
included both thermal radiation onto detector, and heat transfer between detector elements (heat
transfer between elements blurs image). Used FFT of the thermal analysis to determine detector
performance (MTF). Analyzed changes to geometry and insulation between cells, to optimize detector
image quality.

3. Mark S. Curtis
page 3 of 3
Mark.curtis@sbcglobal.net
 For a rifle mounted IR sight, ran a FEA stress analysis on optical parts to determine crack sensitivity,
to determine if glass parts could withstand shock loading. Used SAPIV and ADINA non-linear finite
element programs.
 Laser cutting process development, and experimentation with various materials. Researched laser
induced stress in silicon wafers and in IR detector materials.
 Worked on Hybrid microelectronics packaging using thick and thin film applications. Hand build
prototype units.
 Co-design system to (solder) bump-bond IR detector, to image processing IC; 10k bumps with 3mil
spacing, while in High-Vacuum chamber.
 Worked in lab having thin film deposition and ion mill equipment. Familiar with IC photo lithograph
and etching processes. Designed and built a high-pressure fluid spray photo-resist stripper.
National Institute of Health Bethesda, MD Biomedical Instrumentation
 2 years college internship as engineering technician.
 Assisted with development of implantable fiber optic probes for chem-luminescent studies on tumor
growth rates.
 Assisted development on magnetic-fluid valve for controlling rate of drug delivery.
 Design and fabrication of electronic food-weight measurement system, to track animal’s food intake
vs. cancer growth rate.
Computer
Skills
3D CAD: SolidWorks, EDMS vault. AutoCAD. Customize Excel using VBA. SAP R/3 MM & QM
For dept. web application, used HTML, ASP, VBScript .
Other languages used: Pascal, Fortran, Basic, NeXT Objective C.
Machine control: Rockwell PLC, Anorad and Delta-Tau Servo Motion Controllers.
Courses &
Training
Technical Business/Managerial
MSA Measurement System Analysis Microsoft Project
Gauge R&R How to Handle Difficult People
FDA/QSR Regulations Personnel Law for Managers
Process Validation Motivating Employees
Software Validation Communication Skills
SPC Statistical Quality Improvements Social Styles
Plasma Etching Negotiation Skills
DOE Design of Experiments Meeting Customer Requirements
Taguci 7 Habits of Highly Effective People
JK Laser Operations & Maint. First things First Time Management