Daniel Amador
Toledo,OH
Summary
Manufacturing professional with extensive experience in medical device manufacturing. Known for driving successful operational outcomes and implementing process enhancements. Strong focus on team collaboration and achieving results, adaptable to evolving production needs. Skilled in process optimization and troubleshooting.
Overview
10
10
years of professional experience
Work History
Manufacturing Engineering Supervisor
Fresenius Medical Care NA
11.2021 - Current
- Supervised manufacturing engineering team members, fostering collaboration and communication for efficient project completion.
- Managed project planning for the manufacturing engineering department.
- Provided technical expertise on machine operation and production processes for NC & CAPA investigations.
- Manufacturing site validations subject matter expert (SME).
- Development and execution of process and test method validations (IQ / OQ / PQ / PTMV).
Manufacturing Engineer II
Fresenius Medical Care NA
01.2020 - 11.2021
- Plant Lead Production Officer (LPO) - Responsible for leading lean manufacturing efforts.
- Collaborated with multiple departments to drive production efficiency improvements (OEE).
- Introduction of new manufacturing equipment (FAT / SAT / Validation).
- Development and execution of process and test method validations (IQ / OQ / PQ /PTMV)
- Provide technical support to production and maintenance department for equipment troubleshooting.
- Developed technical documentation, including standard operating procedures, work instructions, and engineering drawings to support manufacturing operations.
Sustaining Engineer
Erika De Reynosa (Fresenius Medical Care MX)
04.2015 - 12.2019
- Conducted regular design reviews with key stakeholders, ensuring alignment with project objectives and facilitating efficient decision-making processes.
- Led design transfer activities for new product introduction
- Managed design changes to existing products
- Developed and sustained material specifications and drawings
- Developed packaging improvement projects
- Introduced and qualified new suppliers
- Supported projects at different manufacturing and distribution sites across the US.
Validations Engineer
Erika De Reynosa (Fresenius Medical Care MX)
01.2015 - 04.2015
- Development and execution of equipment and process validations (IQ / OQ / PQ)
- Development and execution of test method validations (PTMV)
Education
Bachelor of Science - Industrial & Systems Engineering
Instituto Internacional De Estudios Superiores
Reynosa, TAM (MX)07-2014
Skills
- Project management
- Microsoft Software
- Power Bi
- Data Analysis
- NC & CAPA
- Systems Validation
- AutoCAD
- SolidWorks
- Change Control
Accomplishments
- Supervised team of 4 engineers.
- Authored and executed over 30 validations.
- Implemented Power Bi reporting for OEE tracking.
- Implemented automatic Power Bi reporting for production line output and scrap tracking.
- Implemented project to reduce material consumption for dry acid concentrates line.
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
Manufacturing Engineering Supervisor
Fresenius Medical Care NA
11.2021 - Current
Manufacturing Engineer II
Fresenius Medical Care NA
01.2020 - 11.2021
Sustaining Engineer
Erika De Reynosa (Fresenius Medical Care MX)
04.2015 - 12.2019
Validations Engineer
Erika De Reynosa (Fresenius Medical Care MX)
01.2015 - 04.2015
Bachelor of Science - Industrial & Systems Engineering
Instituto Internacional De Estudios Superiores
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