Manufacturing Engineer Contractor

BioPharma Consulting JAD Group has a great Contract Medical Device Manufacturing Engineer role with an industry leader in Houston, TX. This is a temporary position with the possibility of extension.

The candidate will work in a highly collaborative team environment, you will play a crucial role in ensuring the efficient and effective production of ophthalmic medical devices. Your responsibilities will span various stages of the manufacturing process, from validation to continuous improvement. Here’s what you’ll be doing:

Job Responsibilities:

• 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 Ophthalmic medical devices.

• Design, develop, validate and implement manufacturing processes to build ophthalmic medical devices for cataract and vitreoretinal surgeries.

• Support production process optimization through Lean and Six Sigma methodologies.

• Apply the concepts of Continuous 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 with their day-to-day operations.

• Promote cooperation and teamwork with all departments through open, candid communication and timely coordination.

• Create standard work procedures to ensure high quality and robust manufacturing processes

Requirements

• Medical Device Validation (IQ/OQ/PQ)
• Statistical Process Control
• Statistical Analysis: DOEs, ANOVA, Gage R&R, T-Test, Tolerance Analysis Interval, Control Charts and Process Capability.
• Statistical Software (MiniTab)
• CAD Design (i.e. SolidWorks)
• Manufacturing Simulation Software (Flexsim), Preferred, not required.
• Technical Writing
• Public Speaking