Validation Engineer – Medical Device Manufacturing

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 RD 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:
Bachelors 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:
23 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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