Manufacturing Process Engineer

Overview

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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.

Position Summary

The Sourcing Engineer will work within the Product Development process to achieve cost, feature, and performance requirements by increasing manufacturing reliability, accelerating design through minimized iterations, and reducing production complexity.

Essential Functions

• Analyzes new product specifications, translating design inputs into manufacturing processes to establish efficient production rates and reliability of finished product
• Be a technical resource for the initiation and implementation of cost improvement plans on new and existing projects
• Develop and release test fixtures / assembly aides for use in manufacturing
• Overseeing, coordinating, and at times performing design verification and validation activities, to include Part Process Performance Qualifications
• Implement and complete with vendors as well as other process validations as needed
• Collaborating and partnering with product design, product management, quality and operations
• Participate in design reviews and manufacturing meetings to evaluate design and to help identify alternative design solutions
• Participate in verification and validation efforts to identify and mitigate areas of risk
• Perform sustaining activities on released product to address life cycle issues, continuous improvement, reliability, and cost reductions
• Oversee Vendor process risk management during design to production transfer
• Ability to use engineering design software such as Pro / E, Unigraphics, NX, Solidworks, etc. Understanding of design intent and the ability to understand which features of the print can and cannot be changed in order to retain the original intent.
• Experience interacting or running engineering functions within a manufacturing environment
• Possesses effective writing skills for drafting SOPs, protocols, reports, process validations and other manufacturing related documentation
• Understanding of Process FMEAs and Process Validations (IQ, OQ, PQ)
• Understanding of project plans and the launch life cycle
• Understanding of FDA compliance around validations, gauging, Device History Records in design and in manufacturing
• Understanding of RCCA, CAPA, DFMEA, PFMEA, and SCAR
• Adhere to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensure 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
• Represent the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

Physical Demands

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Our Values

Our Life Moves Us philosophy is built on four values : Passionate About Innovation, Customer Focused, Teamwork, and Driven.

Equal Employment Opportunity

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees talents and support an environment that is inclusive and respectful.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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