Medical Device Validation Engineer – IQ/OQ/PQ & NPI

Manpower, Inc.

Añasco (PR)

On-site

USD 32,000 - 45,000

Full time

2 days ago

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Job summary

Manpower, Inc. is seeking a Validation Engineer in Añasco, Puerto Rico (On-Site) to join the Product Development Engineering Department supporting R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams.

The ideal candidate will have strong problem-solving skills, attention to detail, and excellent communication abilities. The role involves validating extrusion processes, contributing to NPI/NPD projects, and ensuring FDA/ISO compliant IQ/OQ/PQ validations while driving process

Qualifications

Bachelor's Degree in Mechanical, Chemical, Polymer, Materials Engineering or related discipline.
2+ years of engineering experience in a regulated environment.
Experience with validation activities including IQ/OQ/PQ.
Knowledge of DOE, statistical analysis, and technical documentation.
Strong troubleshooting, analytical, communication, and organizational skills.

Responsibilities

Support validation, process development, and optimization activities for medical device extrusion processes.
Assist with NPI and NPD projects, ensuring successful transfer from development to production.
Execute and document process validations (IQ/OQ/PQ) in compliance with FDA and ISO requirements.
Collaborate with cross-functional teams including R&D, Manufacturing, Quality, Regulatory, and Supply Chain.
Collect, analyze, and interpret process data to drive quality, yield, and process improvements.