Process Engineer

Oxford Global Resources; Ham Lake (MN); On-site; USD 96,000 - 125,000; Full time

Benefits offered by this job

Supplemental medical (we do not offer/

Dental

Vision

Life insurance

Disability insurance

401(k) Retirement Savings Plan

Paid holidays

Paid sick leave

Accommodation assistance

Job summary

Oxford Global Resources seeks a Process Development Engineer in Minnesota to design and develop manufacturing processes, tooling, and fixturing for next generation delivery catheter systems. You will evaluate production equipment, support production, and interface with vendors to ensure quality and cost objectives.

Responsibilities include executing IQ/OQ/PQ, writing validation reports, developing process documentation, and implementing process improvements while adhering toDesign Control and

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 and provide production support.
• Interface with vendors for incoming components.
• Troubleshoot manufacturing processes and equipment; write protocols and reports.
• Execute IQ/OQ/PQs, Test Method Validation and PPQs.
• Generate and modify manufacturing process documentation; establish processes per print specifications.
• Develop and implement process improvements; ensure compliance with Quality Control requirements.

Skills

Process development

Manufacturing process design

Cross-functional collaboration

Problem solving

Tools

Molding

Catheter shaft bonding

Coating processes

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 writingli>
• 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: 70-91

Equal Employment Opportunity

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

• 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.