Job Description:

• Identify and characterize input variables related to manufacturing or testing processes
• Write and execute validations through methods such as Process Characterization, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Test Method Validations (TMV)
• Continuously improve existing manufacturing processes through lean 6 sigma principles and the integration of new technology
• Partner with design teams to develop appropriate production tooling, perform critical design reviews and procuring tooling and equipment
• Participate in Process Failure Mode and Effects Analysis (PFMEA) and risk-based discussions
• Provide support for the resolution of process related non-conformances
• Interact and collaborate with experts both internal and external
• Design effective screening experiments using Design of Experiments (D.O.E.) tools and methodology
• Basic knowledge of statistics
• Candidate should have good technical writing skills

Job Requirements:

• Bachelor of Science with preferred discipline in one of the following: Mechanical, Electrical, Industrial, Chemical or Biomedical engineering.
• 3-4 years medical device experience
• Six sigma yellow belt or green belt certification
• Experience with statistical analysis software such as Minitab
• Familiarity with project management tools such as Microsoft Project

*Sponsorship/ Corp to Corp is not available for this position.

Check us out at www.medicalengineeringconsultants.com