Innovative Med Device Packaging Validation Engineer

FITS LLC; Añasco (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

FITS LLC in the United States (Puerto Rico, Añasco) is seeking a seasoned Validation Engineer to advance packaging validation for sterile and non-sterile medical device systems. You will collaborate with Quality, Regulatory, and Product Development to execute studies, collect data, and document conclusions.

The ideal candidate holds a Bachelor’s degree in Engineering, at least four years in validation activities, and bilingual Spanish/English.

Qualifications

• Bachelor’s degree in engineering with at least four years in validation activities.
• Bilingual in Spanish and English.
• Experience with packaging validation and testing for medical device packaging systems.
• Familiarity with FDA QSR, ISO 13485, ISO 9001, MDR/CMDR preferred.

Responsibilities

• Support packaging validation and testing activities.
• Assist senior engineers with studies, protocols, and data analysis.
• Coordinate with Quality, Regulatory Affairs, and Operations.
• Maintain and document technical records and change control.

Skills

Packaging validation

Engineering documentation

Statistical analysis

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Job description

FITS LLC in the United States (Puerto Rico, Añasco) is seeking a seasoned Validation Engineer to advance packaging validation for sterile and non-sterile medical device systems. You will collaborate with Quality, Regulatory, and Product Development to execute studies, collect data, and document conclusions.

The ideal candidate holds a Bachelor’s degree in Engineering, at least four years in validation activities, and bilingual Spanish/English.