Manuel Rodriguez
Eastvale,CA
Summary
Engineer with 8+ yrs of Medical Device experience. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
9
9
years of professional experience
Work History
Senior Engineer, Engineer Level II/III
Inari Medical
12.2020 - Current
- Established the manufacturing process for new product, design tooling, conducted DOEs and lead/executed process validation efforts (IQ/OQ/PQ).
- Managed projects post design verification testing through full market release for Triever Gen 4, CT Bold, RevCore, and CT Bold Gen 2.
- Coordinated with cross functional teams to ensure the CT Bold, RevCore and CT Bold Gen 2 devices were launched 1 month before the project timeline due date.
- Conducted root cause investigations, via non-conformance reports (NCRs), to disposition material.
- Worked with cross functional teams on a CAPA to ensure FDA compliance. The CAPA actions consisted of gathering testing data, establishing documentation to record standard compliance, recommending updates to quality procedures, and training team members.
- Established process for ALD Surface Treatment on CT Bold Gen 2. Lead efforts to purchase a second ALD machine to improve production throughput/efficiency.
- Mentored fellow Engineers on tooling design, process development, process improvement/optimization, Non-conformance investigations and technical writing, including Engineering drawings and test protocols/reports.
Engineer Manager, Process Engineer Level II
Applied Medical
12.2017 - 12.2020
- Managed the Voyant Lap Fusion production line consisting of 10 top level devices.
- Mentored engineers on tooling design, process implementation/optimization.
- Reviewed technical drawings, non-conformance reports, CERs, test protocols for process validation (IQ/OQ/PQ) and Test Method validation (TMVs).
- Captured technical schematics for use in project planning and execution.
- Implemented automated systems to improve accuracy and efficiency of engineering processes.
- Optimized engineering processes by implementing innovative solutions and streamlining workflow.
Packaging Engineer
Applied Medical
06.2015 - 12.2017
- Assisted with launch of manufacturing plant in the Netherlands for legacy devices. Purchased Form-Fill & Seal (FFS) packaging equipment, conveyors, boxing weigh scales. Led qualification efforts (IQ/OQ/PQ) of packaging tooling/process. Trained Dutch Engineers in packaging processes, packaging testing, root cause analysis and FFS tooling development.
- Developed FFS tooling for Suction Irrigation device.
- Assisted in converting the sterilization process of medical devices from gamma sterilization to E-beam.
- Implemented automated equipment to streamline the top level packaging process from clean room to boxing.
Education
Bachelor of Science - Bioengineering
University of California, Riverside
06.2015
Skills
- Project planning/project management
- Catheter Manufacturing
- Tooling/Fixturing design
- Laser welding
- Milling
- Lathe
Timeline
Senior Engineer, Engineer Level II/III
Inari Medical
12.2020 - Current
Engineer Manager, Process Engineer Level II
Applied Medical
12.2017 - 12.2020
Packaging Engineer
Applied Medical
06.2015 - 12.2017
Bachelor of Science - Bioengineering
University of California, Riverside
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