Injection Molding Medical Qualifications Expert 
Rex Teitgen

Rex is a manufacturing and engineering executive with deep expertise in plastics, medical devices, quality systems, automation, and operational excellence. He has successfully led product development, manufacturing operations, capital projects, and continuous improvement initiatives across the U.S. and Mexico. Combining technical depth with strong business leadership, Rex specializes in building high-performing teams, solving complex manufacturing challenges, and driving profitable growth.

PROFESSIONAL EXPERIENCE
Gentech, So.
San Francisco, CA
Worked on the medical device portion of a Combination Product

• Coordinated GMP Commissioning and closure of CAPA’s and Audit/Report with Contract Manufacturer (CMO).
• Contributed to and supported design Verification & Validation activities including protocols, testing & test reports.
• Developed FMEA’s per ISO 14971. (pFMEA w/CMO; dFMEA, uFMEA & sFMEA)

Stryker Instruments
Kalamazoo, MI

• Audited on average 2 suppliers per month to FDA and ISO 13485 requirements.
• Authored three validations and test reports for fixtures and provided evidence that the fixtures performed as designed.
• Assured all documentation; drawings, work instructions were up to date and in place. Authored risk documentation.
• Solved a float sinking problem on the Neptune Waste Management product. Eliminated the glass in the plastic and improved the spin welding process.

Interface Catheter Solutions
Laguna Niguel, CA

• Shortened lead times for beryllium copper balloon tooling from over 10 weeks to less than 3 weeks, while increasing tooling throughput by three times. (Without adding equipment or labor – ran EDM lights out at night, updated tooling)
• Avoided over $ 700K in capital expenditures by utilizing existing EDM equipment and improving processes.
• Added finishing cut to EDM cycle, which reduced Honing requirement and Polishing on Hardinge Lathe.

Automated Plastics LLC

• Corrected a problem with a clean room roof mounted rail antistatic device that was catching on fire. Altered the polymer which saved 30% of the material cost and allowed the extruded part to be processed quicker, no more fires.
• Discovered the root cause for a film assembled landscape drip tubing inconsistent drip rate problem. (Volumetric blending at the extruder was not sufficiently accurate or consistent, recommended gravimetric blending)

Chem Lab Products, Inc.
Ontario, CA

• Improved productivity on the household bleach line by over 314%. Approx. $ 412,000 savings per year.
• Developed and implemented an equipment PM system to reduce downtime.
• Successfully passed OSHA Chemical Processing Audit with only 2 minor findings.

Owens-BriGam Medical Co.
Corona, CA

• Improved productivity on main product line, rotational molded mask cushion 500%, while reducing personnel, by reducing the cycle time and improving the tooling.
• Developed rapid tooling system for extruded corrugated breathing tubing.
• Improved the beryllium copper rotational molded mask cushion mold to make the parts water clear.
• Corrected assembly problem that was causing Neonatal Unit ICU fires. (Heated wire breathing circuit)

National Diversified Sales
Lindsay, CA

• Improved capacity by over 34% through process and tooling improvements without increasing labor.
• Improved average gross margins from 34% to 46%, while some resins increased in cost as much as 64%, from $ 0.22/lb to $ 0.37/lb.
• Improved the quality of the products by introducing new standards, improved materials and automating molding process. Decreased scrap rate from 5.7% to 2.8%.
• Received award from Fresno County for using 50% regrind/recycle/post-consumer recycle (PCR).

Sport Court Inc.
Salt Lake City, UT

• Improved capacity by over 34% through process and tooling improvements without increasing labor.
• Improved average gross margins from 34% to 46%, while some resins increased in cost as much as 64%, from $ 0.22/lb to $ 0.37/lb.
• Improved the quality of the products by introducing new standards, improved materials and automating molding process. Decreased scrap rate from 5.7% to 2.8%.
• Received award from Fresno County for using 50% regrind/recycle/post-consumer recycle (PCR).

Hudson RCI
Temecula, CA

• Automated 16 molding machines to be run by one operator
• IQ-OQ-PQ qualified 50 molds/machines per year
• Helped inventor to redesign Nebulizer components so that it wouldn’t spit and sputter
• Developed process to flow around 0.006-inch core pin to eliminate breakage and improved cycle 25%.
• Rebuilt an Autobagger; cycle from 4.7 seconds to 1.7 seconds, hot stamped labeling through 1.5 mil PE tube

The Kendall Company
Chula Vista, CA

• Started up new plant in Mexico. Ran airway management department for first year.
• Responsible for equipment startup: Rotary Silk Screen, Form-Fill-Seal, Ultrasonic Welding, assembly and test fixtures and semi-automated turn tables. (Precision Uson leak detector calibration and implementation) All in Mexico.
• Responsible for placing and coordinating new tooling. Goal to improve capacity, quality, cost.
• Developed a Bellows Lube (Bottle, Caps, Fill & Label) project to replace purchased part. ROI was 9 months.
• Color coded assembly drawings and molded part labels to Poka Yoke/mistake proof assembly errors.

Modcom Inc.
Canby OR

• Implemented processes for mold change, drying material, cleaning barrel & screw for short run production (50 pcs).
• Improved processes so that good parts achieved within first 5 shots after set-up.
• Quoted project that justified three new 50T machines, profits paid for machines in first month of operation.
• Developed secondary/assembly department to be more profitable than the molding department. Increased molding.
• Implemented Zero Defects, SPC and Just-In-Time programs for customers.

EDUCATION
B.S. Industrial Technology, dual emphasis in Polymers/Metallurgy
California State University, Chico

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