Medical Device Process Development Engineer

Oxford Global Resources; Columbus (OH); On-site; USD 81,000 - 106,000; Full time

Job summary

Oxford is seeking a Process Development Engineer to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation delivery catheter systems. Evaluation of production equipment and production support are core responsibilities, with interface to vendors for incoming components.

You will troubleshoot manufacturing processes, document protocols, and execute IQ/OQ/PQs, TMs, and PPQs while driving process improvements and documentation compliance.

Qualifications

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

Responsibilities

• Evaluation of production equipment.
• Production support and process validation.
• Interface with vendors for incoming components.
• Troubleshoot manufacturing process and equipment.
• Protocol and report writing.
• Execute IQ/OQ/PQs, Test Method Validation and PPQs.
• Generate and modify manufacturing process documentation.
• Develop and implement process improvements.
• Establish processes based on product and print specifications.
• Evaluate process and design alternatives based on design for manufacturability principles.

Skills

Engineering experience

Medical devices

Manufacturing processes

Design for manufacturability

Molding

Catheter coating

Job description

Oxford is seeking a Process Development Engineer to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation delivery catheter systems. Evaluation of production equipment and production support are core responsibilities, with interface to vendors for incoming components.

You will troubleshoot manufacturing processes, document protocols, and execute IQ/OQ/PQs, TMs, and PPQs while driving process improvements and documentation compliance.