Katalyst Healthcares and Life Sciences
Roles & Responsibilities:
- M.S. in Engineering or Biomedical Engineering
- 1+ year of professional experience in a Medical Device Manufacturing Environment
- 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.
- pply 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.
- Medical Device Validation (IQ/OQ/PQ).
- Statistical Process Control (SPC).
- 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 Education: B.S. in Engineering or Biomedical Engineering.