Medical Device Validation Engineer – NPI & Process Validation

CorTech LLC; Añasco (PR); On-site; USD 32,000 - 45,000; Full time

Job summary

CorTech LLC seeks a motivated Validation Engineer to support NPI, NPD, and process validation in a medical device manufacturing setting. You will focus on process development, validation, and optimization while ensuring FDA/ISO compliance and quality standards.

The role involves IQ/OQ/PQ validations, DOE studies, data analysis, and collaboration across Engineering, Quality, Manufacturing, Regulatory, and R&D teams. On-site in Añasco with standard full-time hours.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Materials, Polymer or related Engineering field.
• Engineering experience in manufacturing, process development, validation, or a related technical field.
• Knowledge of process validation principles and manufacturing processes.
• Ability to interpret technical data and prepare detailed reports.
• Proficiency in Excel and MS Office.
• Strong written and verbal communication skills.
• Ability to work independently and with cross-functional teams.
• Experience in cleanroom environments is preferred.

Responsibilities

• Support development, validation, and optimization of manufacturing processes for medical device components.
• Execute and document IQ, OQ, and PQ validation activities.
• Support NPI and NPD projects from development to commercial production.
• Assist with DOE, process testing, and statistical data analysis to improve quality.
• Collaborate with Engineering, Quality, Manufacturing, Regulatory, and R&D teams to meet project objectives.
• Develop and maintain validation protocols, technical reports, SOPs, and work instructions.
• Analyze manufacturing data, identify process improvements, and support troubleshooting.
• Participate in equipment qualification, installation, and manufacturing trials.
• Support extrusion process development and optimization for medical tubing components.
• Ensure compliance with FDA regulations, ISO 13485, and internal quality standards.
• Prepare technical documentation and present findings related to process validation.
• Identify opportunities to improve manufacturing efficiency, process capability, and product quality.

Skills

Analytical thinking

Problem-solving

Organizational skills

Communication skills

Excel

Microsoft Office

Education

Bachelor's degree in Mechanical, Chemical, Materials, or Polymer Engineering

Tools

Excel

Microsoft Office

Job description

CorTech LLC seeks a motivated Validation Engineer to support NPI, NPD, and process validation in a medical device manufacturing setting. You will focus on process development, validation, and optimization while ensuring FDA/ISO compliance and quality standards.

The role involves IQ/OQ/PQ validations, DOE studies, data analysis, and collaboration across Engineering, Quality, Manufacturing, Regulatory, and R&D teams. On-site in Añasco with standard full-time hours.