Process Engineer

Oxford Global Resources; Arlington (VA); On-site; USD 84,000 - 110,000; Full time

Benefits offered by this job

Supplemental medical

Dental

Vision

Life insurance

Disability plan

401(k)

Paid holidays

Paid sick leave

Job summary

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

You will evaluate production equipment, support production, validate processes, and interface with vendors. The role includes IQ/OQ/PQ, writing protocols and reports, and implementing process improvements in a cross-functional environment.

Qualifications

• 4+ years engineering experience.
• Experience designing and testing medical devices preferred.
• Experience developing manufacturing processes and design 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

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

Skills

Engineering experience

Medical devices design

Manufacturing process development

Design for manufacturability

Molding

Catheter bonding

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

61-80

Language Required

English

Equality & Diversity

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.

Benefits & Perks

• Oxford provides supplemental medical (we do not offer major medical)
• dental
• vision
• life
• disability benefit plans
• 401(k) Retirement Savings Plan
• Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required

Accommodation and Accessibility

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.