Manufacturing Process Development Specialist

4 weeks ago

Louisville, Kentucky, United States Oxford Global Resources Full time
Job Summary:

As a Process Development and Engineering Expert at Oxford Global Resources, you will play a key role in designing and developing manufacturing processes, technologies, tooling, and fixturing for next-generation delivery catheter systems. Your expertise will be instrumental in evaluating production equipment, providing production support and process validation, and interfacing with vendors for incoming components. You will also be responsible for troubleshooting manufacturing processes and equipment, writing protocols and reports, and executing IQ/OQ/PQs, Test Method Validation, and PPQs. Additionally, you will generate and modify manufacturing process documentation, work with cross-functional teams, develop and implement process improvements, and resolve and/or facilitate the resolution of problems. Your understanding of principles of Cost of Goods Sold and ability to manage program compliance with Quality Control requirements will be essential in this role.

Requirements:

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

What We Offer:

Oxford Global Resources is an Equal Employment Opportunity Employer. We offer a comprehensive benefits package, including supplemental medical, dental, vision, life, and disability benefit plans, as well as a 401(k) Retirement Savings Plan. Paid holidays and paid sick leave are also provided, based on eligibility and applicable jurisdiction. We are 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 us.

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