Process Engineer II

Medial Group; Juncos (PR); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Jobbeschreibung

Juncos, Puerto Rico | Posted on 08/13/2025

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 as well as production yields for existing products. Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. Reviews product development requirements for compatibility with processing methods to determine costs and schedules. Interacts with product design and development personnel to ensure that processes and designs are compatible. May develop and conduct statistical analysis or recommend additions to document work. Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. Ensures processes and procedures are in compliance with regulations.

***Other duties may be assigned.***

Requirements

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. Technical (Troubleshooting), Quality, Process Control and Assurance. Bilingual. Bachelor Degree in Engineering completed. Willing to work 100% on-site in Juncos, PR.

Top 3 things you are looking for in a candidates experience:

• Proficient in validation process, CSV, PV
  
• Proficient in Troubleshooting, Equipment Setups