1. Support Alcon Engineers with 3rd party manufacturing sites to establish manufacturing processes and support equipment implementation.
2. Use statistical tools and statistical process controls to show process capability and stability.
3. Identify failure modes and establish Engineering controls to mitigate process risks.
4. Support writing protocols/reports and executing IQ/PVS/OQ/PQ validation activities 3rd party manufacturing systems.
5. Support the characterization and identification of the manufacturing process-operating window (lows, nominal and highs).
6. Supports Alcon Engineers writing SOPs.
7. Provide support to 3rd party manufacturing site for at least 3 months upon release to production to address any issues.
8. Fixture design in CAD modeling software.
9. Travel to 3rd party manufacturing sites as needed to provide on-site validation support.
Skills
- Medical Device Validation (IQ/OQ/PQ)
-Statistical Analysis: DOEs, ANOVA, Gage R&R, T-Test, Tolerance Analysis Interval, Control Charts and Process Capability.
-Statistical Software (MiniTab)
-Project Management
-CAD Design (i.e. SolidWorks)
-Technical Writing
-Public Speaking
Education:
B.S. in Engineering or Biomedical Engineering
Preferred:
M.S. in Engineering or Biomedical Engineering with 1+ years of experience in the Medical Device Manufacturing Environment
Contract Duration:
Feb 15th, 2022 through Q4 2023
Number of Positions:
1
Assignment Location:
9965 Buffalo Speedway, Houston, TX 77054
Job Types: Full-time, Contract
Pay: $40.00 - $50.00 per hour
Benefits:
- Health insurance
- Paid time off
Schedule:
- 8 hour shift
- Monday to Friday
Education:
Experience:
- Manufacturing: 2 years (Preferred)
Work Location: In person