Sr. Manufacturing Engineer
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling. Arrange machines within plant facilities to ensure efficient layouts and specify procedures for tool fabrication. Adapt equipment design to factory conditions, incorporating inspection and test requirements into production plans. Inspect machinery performance to verify efficiency, initiating corrective actions for product quality issues. Develop statistical process control techniques and ensure all processes comply with regulations. Support manufacturing equipment moves, installations, commissioning, startup, and decommissioning activities while managing facility utilities and equipment integration. Execute equipment qualification (IQ/OQ/PQ), process validation, and cleanroom qualification in adherence to GMP requirements and change control protocols.
Required Qualifications
- Bachelor's Degree in Mechanical or Engineering
- five (5) years of exposure within the Medical Devices Industry
- Bilingual: Spanish and English
- Excellent teamwork skills
- Experience executing manufacturing equipment moves, installations, commissioning, startup, and decommissioning activities
- Knowledge of facility utilities, equipment integration, and manufacturing readiness activities
- Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning validation, and cleanroom qualification
- Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state following equipment or facility changes
- Experience supporting manufacturing layout changes, facility modifications, material and personnel flow assessments
- Ability to evaluate facility, utility, and environmental requirements for regulated manufacturing operations
- Shift: 1st, and according to business needs
Desired Qualifications
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout
- Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance
- Adapts machine or equipment design to factory and production conditions
- May incorporate inspection and test requirements into the production plan
- Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality
- Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques
- Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques
- Ensures processes and procedures are in compliance with regulations
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