Biotech & MDM Support

Advance Technology Consultant supporting Life Sciences Medical Field (Biotech, Medical Device, and Pharma Manufacturing Industries) including:

1. Advanced Engineering Project (Program) Manager, with extensive hands-on skills delivering practical team management while optimizing project schedule and resources facilitating highly effective cross-functional team performance.
2. Product Design including Verification and Validation to product specifications and/or customer requirements. Development of Master Validation Plan for Life Sciences Organizations. Device History File and Records Management and Control.
3. Evaluation of manufacturability of Product Design (Manufacturing Deployment) to meet customer requirements and manufacturing operation metrics. (Yield, Throughput…)
4. Advanced Process Development using Six Sigma/Lean Methodology, Design of Experiments (Screening, Characterization, or Robust DOE Studies), Test Method Validation Development, Measurement System Improvement and evaluation through Type 1 GR&R (Bias & Linearity Assessments) and GR&R (Repeatability & Reliability Assessments) studies. Hands-on statistical analysis expertise allowing reliable data analysis and reporting.
5. Extensive expertise in Non-Ionizing Radiation Medical Applications including Nuclear Magnetic Resonance (NMR), Radio Frequency (RF) and Laser Material Processing.
6. Opto-Mechanical Systems Design and integration for laser beam delivery. Vision System Design and Implementation.

For support in MDM & Biotech, reach out by email, or LinkedIn Profile:

sebastian@technolaser.us

https://www.linkedin.com/in/jsceballos/