Process Development Engineer - Medical Devices Manufacturing

Oxford Global Resources; Portland (OR); On-site; USD 99,000 - 129,000; Full time

Job summary

Oxford Global Resources in Portland, Oregon is seeking a Process Development Engineer to design and develop manufacturing processes, tooling, and fixturing for next generation delivery catheter systems.

The role involves IQ/OQ/PQ execution, process validation, cross-functional collaboration, and ongoing process improvements to meet design specifications, cost targets, and quality controls.

Qualifications

• 4 years engineering experience.
• Experience designing and testing medical devices preferred.
• Experience developing manufacturing processes and manufacturability.
• Experience in a cross-divisional enterprise model preferred.
• Experience with molding, catheter shaft construction/bonding, or coating processes preferred.

Responsibilities

• Evaluate production equipment and provide process validation.
• Interface with vendors for incoming components.
• Troubleshoot manufacturing processes and equipment.
• Write and update protocol and test methods.
• Execute IQ/OQ/PQs and PPQs; ensure design control compliance.
• Develop and modify manufacturing process documentation.
• Lead process improvement initiatives and cost of goods analyses.

Skills

Process development

Manufacturing processes

Design for manufacturability

Quality control

IQ/OQ/PQ

Protocol writing

Troubleshooting

Cross-functional

Job description

Oxford Global Resources in Portland, Oregon is seeking a Process Development Engineer to design and develop manufacturing processes, tooling, and fixturing for next generation delivery catheter systems.

The role involves IQ/OQ/PQ execution, process validation, cross-functional collaboration, and ongoing process improvements to meet design specifications, cost targets, and quality controls.