Validation Engineer – Medical Device Manufacturing

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

Job Title: Validation Engineer – Medical Device Manufacturing

Job Description: Validation Engineer – Medical Device Manufacturing Pay Rate: $28.00 per hour Schedule: Monday – Friday | 8:00 AM – 5:00 PM Work Location: On-site - Añasco Job Type: Full-Time

Job Summary

We are seeking a motivated and detail-oriented Validation Engineer to support New Product Introduction (NPI), New Product Development (NPD), and process validation activities within a medical device manufacturing environment. The ideal candidate will have a background in engineering, strong analytical and problem-solving skills, and experience working in a regulated manufacturing environment. This position will focus on supporting process development, validation, and optimization of medical device components while ensuring compliance with FDA, ISO, and internal quality standards.

Key Responsibilities

• Support the development, validation, and optimization of manufacturing processes for medical device components.
• Execute and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support New Product Introduction (NPI) and New Product Development (NPD) projects from initial development through commercial production.
• Assist with Design of Experiments (DOE), process testing, and statistical data analysis to improve product quality and manufacturing performance.
• Collaborate with Engineering, Quality, Manufacturing, Regulatory, and R&D teams to meet project objectives.
• Develop and maintain validation protocols, technical reports, standard operating procedures (SOPs), and work instructions.
• Analyze manufacturing data, identify process improvements, and support troubleshooting activities.
• Participate in equipment qualification, installation, and manufacturing trials.
• Support extrusion process development and optimization for medical tubing and components.
• Ensure compliance with FDA regulations, ISO standards, and company quality and safety procedures.
• Prepare technical documentation and present findings related to process validation and product development.
• Identify opportunities to improve manufacturing efficiency, process capability, and product quality.

Qualifications

Required:

• Bachelor's degree in Mechanical, Chemical, Materials, Polymer, or a related Engineering discipline.
• Engineering experience in manufacturing, process development, validation, or a related technical field.
• Knowledge of process validation principles, manufacturing processes, and technical documentation.
• Strong analytical, organizational, and problem-solving skills.
• Ability to interpret technical data and prepare detailed reports.
• Proficiency in Microsoft Office applications, particularly Excel.
• Strong written and verbal communication skills.
• Ability to work independently and collaborate with cross-functional teams.
• Comfortable working in manufacturing and cleanroom environments.

Preferred:

• 2–3 years of engineering experience in a regulated manufacturing environment.
• Experience in medical device manufacturing.
• Hands-on experience executing IQ/OQ/PQ validations.
• Experience with polymer extrusion processes, particularly medical tubing.
• Knowledge of FDA regulations, ISO 13485, and quality management systems.
• Experience with Design of Experiments (DOE), statistical analysis, and process capability studies.
• Previous involvement in NPI/NPD projects.

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