Sr. Manufacturing Engineer

Flexible & Integrated Technical Services, LLC•Juncos, PR

7d•Onsite

About The Position

We are seeking a Sr. Manufacturing Engineer to join our team and provide Engineering services in the Manufacturing area. This role is crucial for designing and optimizing manufacturing processes, ensuring equipment efficiency, and maintaining compliance with industry regulations, particularly within the Medical Devices sector.

Requirements

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 in Equipment Relocation, Installation & Decommissioning
Experience in Process Validation
Experience in Manufacturing Process & Facility Change Management
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.

Nice To Haves

Treats everyone they meet like family, especially our resources, clients, and team members.
Customer service skills.
Full of bright ideas and eager to innovate.
Always bringing top-quality results to the table.

Responsibilities

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.
Executes manufacturing equipment moves, installations, commissioning, startup, and decommissioning activities.
Evaluates facility, utility, and environmental requirements for regulated manufacturing operations.