Process Development Engineer - Medical Devices (Catheters)

Oxford Global Resources; Louisville (CO); Sur place; USD 94 000 - 121 000; Plein temps

Avantages offerts par ce poste

Supplemental medical plans

Dental and vision coverage

Life and disability insurance

401(k) Retirement Savings Plan

Paid holidays and sick leave

Accommodation support

Résumé du poste

Oxford Global Resources is seeking a Process Development Engineer to design and develop manufacturing processes, tooling, and fixturing for next-generation delivery catheter systems. You will evaluate production equipment, support production, and validate processes in a cross-functional environment.

The role involves IQ/OQ/PQ execution, protocol writing, and implementing process improvements while ensuring compliance with design control and quality requirements.

Qualifications

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

Responsabilités

• Evaluate production equipment.
• Production support and process validation.
• Interface with vendors for incoming components.
• Troubleshoot manufacturing process and equipment.
• Execute IQ/OQ/PQs, Test Method Validation and PPQs.
• Generate and modify manufacturing process documentation.
• Work with cross functional teams as required.
• Develop and implement process improvements.
• Establish processes based on product and print specifications.
• Evaluate process and design alternatives based on design for manufacturability principles.
• Understand Cost of Goods Sold.
• Manage program compliance with Quality Control requirements.

Connaissances

Engineering experience

Medical devices knowledge

Process development

Design for manufacturability

Cross-functional teamwork

Description du poste

Oxford Global Resources is seeking a Process Development Engineer to design and develop manufacturing processes, tooling, and fixturing for next-generation delivery catheter systems. You will evaluate production equipment, support production, and validate processes in a cross-functional environment.

The role involves IQ/OQ/PQ execution, protocol writing, and implementing process improvements while ensuring compliance with design control and quality requirements.