About Us:

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 Manufacturing 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, translates design inputs into manufacturing processes to establish efficient production rates and reliability of finished product
• Is a technical resource for the initiation and implementation of cost improvement plans on new and existing projects
• Develops and releases test fixtures/assembly aides for use in manufacturing
• Oversees, coordinates, and at times performs design verification and validation activities, to include Part Process Performance Qualifications
• Implements and completes with vendors as well as other process validations as needed
• Collaborates and partners with product design, product management, quality and operations
• Participates in design reviews and manufacturing meetings to evaluate design and to help identify alternative design solutions
• Participates in verification and validation efforts to identify and mitigate areas of risk
• Performs sustaining activities on released product to address life cycle issues, continuous improvement, reliability, and cost reductions
• Oversees Vendor process risk management during design to production transfer
• Utilizes 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
• Drafts SOP’s, protocols, reports, process validations and other manufacturing related documentation
• Understands Process FMEAs and Process Validations (IQ, OQ, PQ)
• Understands project plans and the launch life cycle
• Understands FDA compliance around validations, gauging, Device History Records in design and in manufacturing
• Understands RCCA, CAPA’s, DFMEA, PFMEA, and SCAR
• Adheres 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
• Represents 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 

Qualifications:

• Minimum of 4 years of mechanical or development engineering experience – preferably in the Medical Device field; Bachelor’s Degree in Engineering
• Experience with ISO requirements, FDA Regulations, and cGMP’s
• Experiencing interacting or running engineering functions within a manufacturing environment
• Ability to work independently and as a key contributor in small teams
• Excellent oral, written, and graphical communication skills
• Proficient in Windows, Microsoft Office
• Ability to travel up to 10% of the time  

Our Values: 

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

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions
• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency
• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger
• Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. 

Physical Demands: 

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

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds

Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus. 

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.

JOB CODE: 1002122