Certificate Programs

Quality Engineering for Regulated Medical Technologies

Quality engineering principles are mandated by federal and state regulations for clinical facilities and for the design, testing, and manufacture of medical technologies (such as pharmaceuticals and imaging, diagnostic, and therapeutic devices). Completion of this certificate requires specific instruction in quality engineering and regulation of medical technologies; moreover, candidates must go beyond understanding concepts and demonstrate appropriate usage of quality engineering principles in a medically related internship. Given the challenging demands for both better outcomes and lower costs in medical care, candidates for this certificate are expected to be entering a high-growth job market for engineers.

Course Requirement Summary

Prefix &                       
Number                       
Required Internship (Choose 1)SCH             
BMEN 
653
Bioinnovation I (instructor approval required to join course) 3
XXEN
399/485
Internship (position must be approved by certificate faculty to meet experience needs) 3
XXEN
684
Internship (position must be approved by certificate faculty to meet experience needs)

Prefix &    
Number    
Required Courses (Choose 2-3)SCH  
BMEN
404/604
FDA Good Laboratory and Clinical Practices   3
BMEN
406/606
Medical Device Path to Market
OR
3
BMEN
469/669
Entrepreneurial Issues in Biomedical Engineering 3
ISEN
350
Quality Engineering
OR
3
ISEN
614
Advanced Quality Control 3
Prefix & 
Number 
Prescribed Elective Courses (Choose 0-1)SCH
BMEN
654
Bioinnovation II 3
ISEN
414
Total Quality Engineering 3
ISEN
434
Human Error & System Failures 3
MMET
418
Medical Manufacturing 3
VTMI
629
Laboratory Quality Systems 3

Engineering Therapeutics Manufacturing

Engineering Therapeutics Manufacturing Certificate is intended to meet the requirements of industry by education engineering BS graduates to economically, ecologically and safely design and operate equipment used for the production and separation of biological materials. By the end of the certificate program, students will be able to:

  1. Understand the processing of biological materials
  2. Analyze functions and properties of biological materials
  3. Understand the impact of the use/misuse of biological materials
  4. Understand the life cycle and evolution of biological materials
  5. Design, operate and optimize biological process units

Course Requirement Summary

Required Courses: (Choose one)

CreditCourse
3 BAEN 302 - Biological and Ag Engineering Fundamentals II (OR equivalent)
3 BAEN 601 - Advanced Agriculture Systems Analysis
3 CHEN 382 - Bioprocess Engineering
3 CHEN 651 - Biochemical Engineering
3 ISEN 360 - Lean Thinking and Lean Engineering in Process Industries
3 ISEN 645 Lean Thinking and Lean Manufacturing
3 VTPP 435 - Physiology for Biomedical Engineers II

Prescribed Elective Courses (Choose Three)

CreditCourse
3 BAEN 471 - Biochemical Engineering
3 BAEN 479 - Biological and Agricultural Engineering Design I
3 BAEN 489 - Introductions to Separations
3 BAEN 631 - Bioprocesses and Separations in Biotechnology
3 BAEN 653 - Bioreactor Design
3 BMEN 430 - Medical Device Regulations
3 BMEN 440 - Design of Medical Devices
3 BMEN 486 - Biomedical Nanotechnology
3 BMEN 487 - Drug Delivery
3 BMEN 630 - Medical Device Regulations
3 BMEN 640 - Design of Medical Devices
3 BMEN 686 - Biomedical Nanotechnology
3 BMEN 687 - Drug Delivery
3 CHEN 440 - Introduction to Transport Phenomena
3 CHEN 463 - Systems Biology
3 CHEN 471 - Introduction to Biochemical Engineering
3 CHEN 489 - Bioprocess Control
3 CHEN 489 - Bioreactor Design
3 CHEN 489 - Introduction to Bioseparation
3 CHEN 489 - Safety in Pharmaceutical and Biotechnology Industries
3 CHEN 489 - Designing for Flexibility
3 CHEN 614 - Advanced Transport Phenomena I
3 CHEN 624 - Chemical Engineering Kinetics and Reactor Design
3 CHEN 629 - Transport Phenomena
3 CHEN 631 - Process Dynamics and Advanced Process Control
3 CHEN 651 - Biochemical Engineering
3 CHEN 655 - Process Safety Engineering
3 CHEN 663 - Systems Biology
3 ISEN 303 - Engineering Economic Analysis
3 ISEN 613 - Engineering Data Analysis

Certificate Worksheet

For more information

Maria Lyons
Academic Advisor III
Biomedical Engineering
3120 TAMU
College Station, TX 77843-3120

Email: bmen@tamu.edu
Phone: 979.845.2312