Process Engineer II - Validation & Optimization

Medial Group; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Medial Group in Juncos, Puerto Rico is seeking an engineer to provide technical and sustaining engineering support in a manufacturing environment. The role focuses on recommending and implementing equipment and process changes to meet quality standards, improve production efficiency, and align materials and tooling with target specifications.

The candidate should have at least 4 years in a regulated Medical Devices setting, with experience in change control, commissioning, qualification, process

Qualifications

• Minimum 4 years of experience in the regulated industry, preferably in Medical Devices.
• Experience in Change control of Medical Devices, Equipment Commissioning / Qualification, Process Validation, CSV, Manufacturing, Packaging and Laboratory Equipment.
• Bachelor Degree in Engineering completed.

Responsibilities

• Provides technical and sustaining engineering support in a manufacturing area.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques and production yields for existing products.
• Interacts with product design and development personnel to ensure processes and designs are compatible.
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
• Develops manufacturing processes applicable to statistical process control and ensures compliance with regulations.

Job description

Medial Group in Juncos, Puerto Rico is seeking an engineer to provide technical and sustaining engineering support in a manufacturing environment. The role focuses on recommending and implementing equipment and process changes to meet quality standards, improve production efficiency, and align materials and tooling with target specifications.

The candidate should have at least 4 years in a regulated Medical Devices setting, with experience in change control, commissioning, qualification, process