Process Engineer

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

Summary:

Process Development Engineer to design and develop manufacturing processes, technologies, tooling, and fixturing for next generation delivery catheter systems

Project Details:

Evaluation of production equipment Production support and process validation Interface with vendors for incoming components Troubleshoot manufacturing process and equipment Protocol and report writing Execution of 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 Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence Establish processes based on product and print specifications Evaluate process and design alternatives based on design for manufacturability principles Understands principles of Cost of Goods Sold Manage program compliance with Quality Control requirements (i.e. Design Control, Process validation etc.).

Job Experience:

• 4 years engineering experience
• Experience designing and testing medical devices preferred
• Experience developing manufacturing processes and technologies 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

Hourly Rate:

72-94

Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email [e-mail]. We will make a determination on your request for reasonable accommodation on a case-by-case basis.