R&D Validation Engineer — Medical Devices (IQ/TQF, DOE)

FITS LLC; Dorado (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC is seeking a Process Development Engineer to support equipment validation and tool qualification activities in the medical devices/pharmaceutical sector. You will design and review validation protocols, develop DOE plans, and generate technical documentation.

Fluency in English and Spanish is required, with an administrative shift as needed, and collaboration across Process Development and R&D. Responsibilities include designing tools in SolidWorks, supporting new processes, and

Qualifications

• Bachelor's degree in Engineering and at least five (5) years of experience in the medical devices or pharmaceutical industry.
• Bilingual: English and Spanish.
• Shift: Administrative, and according to business needs.

Responsibilities

• Support equipment validation (IQ) and tool qualification (TQF) activities.
• Develop and review equipment validation protocols and reports, while supporting other functional areas throughout validation activities.
• Design, update, and review tools and fixtures using SolidWorks to meet product and test method requirements.
• Collaborate with Process Development to qualify new processes, including support for statistical sampling plans and development activities.
• Design and develop in-process and receiving quality systems for new processes and components.
• Generate equipment documentation, including equipment entries, evaluations, PM, and calibration procedures.
• Define the gauges, tools, and equipment required for newly developed test methods and generate associated manufacturing instructions.
• Design, document, and execute experimental protocols, including DOE, and perform data analysis to identify issues and recommend solutions.
• Summarize experimental results and generate technical reports and supporting documentation.
• Work cross-functionally with Process Development, R&D, and other departments to accomplish project objectives and support the evaluation of new technologies.

Skills

Equipment validation

Validation protocols

Statistical sampling

DOE

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

SolidWorks

Job description

FITS LLC is seeking a Process Development Engineer to support equipment validation and tool qualification activities in the medical devices/pharmaceutical sector. You will design and review validation protocols, develop DOE plans, and generate technical documentation.

Fluency in English and Spanish is required, with an administrative shift as needed, and collaboration across Process Development and R&D. Responsibilities include designing tools in SolidWorks, supporting new processes, and