Senior Manufacturing Engineer

Nuvasive Manufacturing - West Carrollton, OH

Full-time - Mid Level

West Carrollton, OH

Miscellaneous Manufacturing

About the position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. As a Senior Manufacturing Engineer, you will conduct process development activities, including the creation of Standard Operating Procedures (SOPs) for machine and/or equipment operation. You will perform design reviews that incorporate a detail-oriented perspective on the impact of specific dimensional accuracy and overall integrity of produced parts. Supporting the implementation of manufacturing processes that require qualification and/or validation of new equipment or processes will be a key part of your role. You will interface with suppliers on technical issues and new product introductions, ensuring that designs are reviewed in both the development and production phases to assure effective use of Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Inspection (DFI). Collaboration with Development/Design Engineering, Quality Engineering, QC/metrology, Programmers, and machinists will be essential to create effective designs and drawings. Additionally, you will develop business processes and metrics, tracking tools for deliverables, and execute the Engineering Change Process while implementing process updates and improvement efforts. Upholding the company Code of Conduct and ensuring compliance with applicable governmental laws, rules, and regulations will be critical. You will represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with employees, customers, suppliers, and other third parties. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Responsibilities

• Conducts process development activities, including creation of Standard Operating Procedures (SOPs) for machine and/or equipment operation.
• Performs design reviews that incorporate a detail-oriented perspective on the impact of specific dimensional accuracy and overall integrity of produced parts.
• Supports implementation of manufacturing processes that require qualification and/or validation of new equipment or processes.
• Interfaces with suppliers on technical issues and new product introductions.
• Reviews designs in both the development and production phases to assure effective use of DFM/DFA/DFI, collaborating with Development/Design Engineering, Quality Engineering, QC/metrology, Programmers, and machinists to create designs and drawings.
• Develops business processes and metrics and tracking tools for deliverables the department is responsible for completing.
• Executes Engineering Change Process and implements process updates and improvement efforts.
• Adheres to the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
• Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions.

Requirements

• Typically requires a minimum of 5 years of related experience with a Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent work experience.
• Bachelor's degree in an engineering discipline preferred.
• Experience in 21 CFR 820 and/or ISO 13485 regulated environment.
• Experience in medical and/or 3D printing preferred.
• Proficiency with Microsoft Office with a strong ability to write procedures and reports.
• Able to effectively influence others, develop consensus, and create support throughout the organization.
• Demonstrated ability to implement, maintain, analyze and react to various production performance metrics and KPIs.
• Demonstrated ability and fluency in Reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma, and Gage/fixture design.