Arely Burgos
Mechanical Engineer
Naguabo, PR
Mechanical Engineer with four (5) year experience in the Medical Device Industry as a Manufacturing Engineer at Pall Life Sciences. I have vast experience in generating and executing equipment and process validations. As well as knowledge in the following FDA Regulations: 21 CFR Part 211 (cGMP) and CRF 21 Part 11. I also have experience in applications of Process Failure Mode and Effect Analysis. Trained in Pall Life Sciences 6σ- Lean Green Belt (DMAIC) methodologies. Excellent project management, leadership, interpersonal and communication (written and oral) skills.
Work Experience
Manufacturing Engineer
May 2006 to August 2011
• Responsible for qualification, characterization and optimization of Ultrasonic welding procedures.
• Implementation of Standard Operational Procedures and improvement on troubleshooting in manufacturing line processes.
• Products transfer support.
• Reduced the generation of product non-conformance investigations through the establishment of daily metrics and the implementation of appropriate corrective/preventive actions.
• Developed and executed Process Validations Protocols. Trained and implemented Process controls at production area impacted.
• Established standard time studies for manufacturing areas.
• Provided on time response, solutions and closure of Product Non-conformances, corrective maintenance investigations, equipment qualifications and corrective/preventive actions.
• Responsible in the developing of equipment preventive maintenance jobs.
• Responsible for the identification of spare parts and calibration points for new and existing equipments.
Support Engineer
October 2005 to October 2005
• Responsible for qualification, characterization and optimization of Ultrasonic welding procedures.
• Implementation of Standard Operational Procedures and improvement on troubleshooting in manufacturing line processes.
• Plastic components Molds transfer supports.
Co-op Engineer
July 2004 to June 2005
• Responsible for the verification and upgrade of products bill of materials and routers in order to reflect current manufacturing processes.
• Established standard time studies for manufacturing areas.
• Responsible for qualification, characterization and optimization of Barbing process.
• Injection molding process support.
Education
B.S. in Mechanical Engineering- (May 2005) – Cum Laude
January 2005
Skills
Skills • Fully Bilingual (English & Spanish) • Capacity to work in team and under pressure • Excellent interpersonal, written and oral communication skills • Excellent leadership skills • Microsoft Office®, Microsoft Project®, Minitab 14®, Maximo • Auto CAD and Solid Works
Awards
• Q3FY09 Pall Life Sciences President Award
September 2009
Certifications
EIT Certification
September 2005 to Present
Certified Six Sigma Green Belt
October 2009
Groups
CIAPR Active Member
August 2009 to Present
