Job Description

Must be w-2

Description

• 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 appropiately 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.

Skills

• 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.

• Public Speaking 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.

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