Manufacturing Engineer I
About The Position
Responsibilities may include the following: Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling. Develop and optimize workflow and sequence of operations to improve efficiency and productivity. Design equipment and facility layouts to maximize production capabilities. Adapt machine and equipment designs to meet manufacturing and production requirements. Incorporate inspection and testing requirements into production processes. Evaluate equipment performance and implement corrective actions to resolve issues. Support statistical process control (SPC) and continuous improvement initiatives. Provide engineering support for design concepts and manufacturability. Ensure compliance with FDA, ISO, and GMP regulations. Collaborate with cross-functional teams including Quality, Operations, and R&D. Other duties may be assigned.
Requirements
- Bachelor’s Degree in Engineering (Mechanical, Electrical, Chemical, or related).
- 0–3 years of experience in manufacturing, engineering, or related roles.
- Bilingual (English & Spanish).
- Experience in Computer System Validation (CSV).
- Experience working in a regulated environment (Medical Devices or Pharmaceutical industry).
- Basic knowledge of manufacturing processes and equipment.
- Strong organizational, communication, and technical writing skills.
Nice To Haves
- Knowledge of Process Validation (IQ/OQ/PQ)
- Experience with Statistical Tools (Minitab or equivalent)
- Familiarity with MES systems (e.g., FactoryWorks)
- Knowledge of risk management tools (FMEA)
Responsibilities
- Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, machining, and material handling.
- Develop and optimize workflow and sequence of operations to improve efficiency and productivity.
- Design equipment and facility layouts to maximize production capabilities.
- Adapt machine and equipment designs to meet manufacturing and production requirements.
- Incorporate inspection and testing requirements into production processes.
- Evaluate equipment performance and implement corrective actions to resolve issues.
- Support statistical process control (SPC) and continuous improvement initiatives.
- Provide engineering support for design concepts and manufacturability.
- Ensure compliance with FDA, ISO, and GMP regulations.
- Collaborate with cross-functional teams including Quality, Operations, and R&D.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
