Process Engineer

Oxford Global Resources; Louisville (CO); On-site; USD 94,000 - 121,000; Full time

Benefits offered by this job

Supplemental medical plans

Dental and vision coverage

Life and disability insurance

401(k) Retirement Savings Plan

Paid holidays and sick leave

Accommodation support

Job summary

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.

Responsibilities

• 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.

Skills

Engineering experience

Medical devices knowledge

Process development

Design for manufacturability

Cross-functional teamwork

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

Hourly Rate: 68-88

Benefits

• 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‑based basis.

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.