Designs and plans layout for activities such as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapts machine or equipment design to factory and production conditions. 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. 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.
Duties/Responsibilities:
Process Development and documentation
Equipment validation
SOP Development
Line layout and infrastructure and development
MES (Manufacturing Execution System)
Special Build Documentation and Line Support
Preferred Qualifications:
Experience in equipment IQ
Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
Process Validation Lifecycle ( from process characterization, operational qualification to performance qualification)
Preferred experience in DOE (with Minitab)
Other Skills:
Computer and software validation CSV
SOP Development
Change control of Medical Devices
MES system
Education/Experience:
Bachelor of Science in Engineering with 3 to 5 years of experience, preferably in Medical Device Industry.
Job Types: Full-time, Contract
Benefits:
Paid time off
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor's (Required)
Experience:
Engineering: 3 years (Preferred)
Equipment Validation: 3 years (Preferred)
CSV: 3 years (Preferred)
Language:
Bilingual (English/Spanish) (Preferred)
Ability to Commute:
Villalba, PR 00766 (Preferred)
Ability to Relocate:
Villalba, PR 00766: Relocate before starting work (Preferred)
Work Location: In person