Job title: Manufacturing Engineer II
Location: Houston, TX (Onsite)
Duration: 12 months
Working Hours: M-F 8am-5pm
Job Description:
The Manufacturing Engineer Contractor will:
-Lead, execute, document & manage the validation activities (IQ/OQ/PQ) necessary to support the introduction or revision of automated and semi-automated production equipment and processes for Ophtalmic medical devices.
-Design, develop, validate and implement manufacturing processes to build opthalmic medical devices for cataract and vitroretinal surgeries.
-Support production process optimization through Lean and Six Sigma methodologies.
-Apply the concepts of Continous Monitoring through Statistical Process Control (SPC) to ensure the processes that have been transferred into production are being monitored and controlled appropriately to maintain the equipment in a validated state.
-Continuous statistical analysis of Critical Quality Attributes and Indicators to ensure the existing processes are capable of meeting the product specification (CpK/Process Capability).
-Hands-on support of manufacturing equipment before, during and after release to production.
-Design fixtures and create drawings in CAD software (i.e. SolidWorks) to support Production withtheir day-to-day operations.
-Promote cooperation and teamwork with all departments through open, candid communicationand timely coordination.
-Create standard work procedures to ensure high quality and robust manufacturing processes.
-Maintain project schedules and timelines.
Skills:
-Medical Device Validation (IQ/OQ/PQ)
-Statistical Process Control
-Statistical Analysis: DOEs, ANOVA, Gage R&R, T-Test, Tolerance Analysis Interval, Control Chartsand Process Capability.
-Statistical Software (MiniTab)
-CAD Design (i.e. SolidWorks)
-Manufacturing Simulation Software (Flexsim)- Preferred, not required.
-Technical Writing
-Public Speaking
-Project and Time Management - Preferred, not required.
Education:
B.S. in Engineering or Biomedical Engineering
Preferred: M.S. in Engineering or Biomedical Engineering
1+ year of professional experience in a Medical Device Manufacturing Environment.
