Manufacturing Engineer

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait.

Position Summary:

The Manufacturing Engineer is responsible ensuring manufacturability and testability of product designs and ensure supply chain, manufacturing processes, tools and equipment are in place and capable of delivering Class III implantable Neuromodulation system for pain management. This effort includes, but is not limited to, sets up and operates production equipment for troubleshooting programs, process validation. This individual works with department managers, supervisors, and operators to ensure product quality and throughput.

Essential Functions:

• Evaluates production equipment to support process improvements, capacity and cycle time requirements
• Leads the acquisition, installation and qualification of production equipment and tooling, including writing the IQ, OQ, PQ documentation
• Understands manufacturing and problem-solving concepts like Value Stream mapping, 5S and DMAIC to improve quality, labor efficiency, and throughput
• Leads, participates and proposes suitability solutions for production and improve manufacturability
• Manages and maintains MP (manufacturing procedure) through the change order process
• Drives regular production meetings to monitor manufacturing line performance metrics/line health (First pass yield, Scrap Rate, NC rate)
• Utilizes tools such Gage R&R, Cp, Cpk, and SPC to ensure capable processes and improve process and first pass yield and eliminate scrap
• Works with Quality counterpart to address manufacturing nonconformances and customer complaint
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/contro
• Adheres to the letter and spirit of 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 uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

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

Qualifications:

• B.S. Mechanical/Electrical Engineering. Advanced degree (M.S.) is preferred
• A minimum of 3 years of experience within the Medical Device industry, preferably manufacturing and/or designing Active Implantable Medical Devices (AIMDs) preferred
• Knowledge of ISO 13485, Current US Food and Drug Administration -Quality System Regulations
• Strong project leadership skills, utilizing structured project management tools
• Experience managing component suppliers
• Prior experience with manufacturing transfers
• Strong electro-mechanical design/manufacturing and analysis skills
• Experience with Solidworks and Six Sigma Certification a plus
• Good analytical and problem-solving skills
• Good problem solving and decision-making skills
• Must be organized, detail-oriented and adaptable
• Strong organizational and follow-up skills
• Excellent verbal and written communication skills
• Attention to detail
• Self-starter
• Advanced critical thinking and problems-solving skills
• Proficiency in using Microsoft Office products

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 15 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.

Our Values:

Our Life M