For Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT: The Technical Part:- Bachelor's Degree in Mechanical orEngineering and five (5) years of exposure within the Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent teamwork skills
- Shift: 1st, and according to business needs.
- Experience in:
- Equipment Relocation, Installation & Decommissioning
- Process Validation
- Manufacturing Process & Facility Change Management
The Personality Part: - Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)- 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.
- 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.
