Manufacturing Engineer I
Flexible & Integrated Technical Services View all jobs
- Villalba, PR
- Permanent
- Full-time
- Bachelor’s Degree in Engineering and two (2) 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:
- Validation of manufacturing processes and equipment
- CSV Equipment Validation.
- Cross-functional team collaboration
- 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?
- Experience in performing software and computer equipment validation.
- Highly desirable previous experience executing CSV validation of Equipment Controller in a Medtronic facility.
- Familiar with validation requirements in regulated industry.
- Capable of developing software qualification protocols and reports.
- Must be capable of working independently with general supervision.
- Must collaborate with engineering process owners in development and execution of protocols.
- Must negotiate with operations and engineering process owners maintenance windows to execute protocols.
- Perform CSV on computers that are reserved for FW Pulse and require the use of a revision of an EC or EF that is different from the one currently in use in production.
- Prepare CSV protocols, execute them, and prepare reports that demonstrate that the new computer will function exactly as intended.