Senior Manufacturing Engineer

We are now seeking a Senior Manufacturing Engineer for our growing engineering team. If you have a heart for patients with brain tumors, the passion for continuous improvements, and a strong balance of strategy and tactical execution, we'd love to talk to you! Position Summary The Senior Manufacturing Engineer supports the production of medical device manufacturing processes and equipment. Key responsibilities of the role include problem-solving complex issues, identifying areas of improvement along with associated plans and solutions to execute accordingly, effective use of documentation and statistical techniques, and driving continuous improvement to the device platform. This position serves as a coach and mentor to Manufacturing Engineer I & II employees. Job Duties/Responsibilities Design/improve layout of equipment or workspaces to achieve maximum efficiency. Design/improve, install, qualify, or troubleshoot manufacturing/facility equipment. Lead and execute preventive maintenance program for equipment and facility. Apply continuous improvement methods such as lean manufacturing to enhance manufacturing quality, reliability, or cost-effectiveness. Identify opportunities or implement changes to improve products or reduce costs using processes, tooling and production equipment, assembly methods, quality control standards, or product design, materials and parts. Communicate manufacturing capabilities to facilitate production processes. Design testing methods and test finished products or process capabilities to establish standards or validate process requirements. Determine root causes of failures using statistical methods and recommend changes in designs, tolerances, or processing methods. Estimate costs, production times, or staffing requirements for new designs. Evaluate manufactured products according to specifications and quality standards. Incorporate new methods and processes to improve existing operations. Investigate or resolve operational problems, such as material use variances or bottlenecks. Collaborate with cross-functional teams in the execution of non-conformances and CAPAs. Prepare documentation for new manufacturing processes or engineering procedures for NPI's. Purchase equipment, materials, or parts. Review product designs for manufacturability for completeness. Support the product realization and serve as a backup for device assemblers. Provide coaching and mentoring for Manufacturing Engineer I level employees. Embody the Company's purpose and shared values, building a positive and productive team culture. Comply with Company policies and procedures. Authorized to access employee and/or patient PHI and ePHI only as needed for job-related functions. Other duties as assigned. Qualifications BS degree or equivalent experience in mechanical, industrial, or electrical engineering. MS degree in related field preferred. Minimum 7 years of experience in a manufacturing environment, preferably medical device manufacturing. Manufacturing experience in a radiation-controlled environment preferred. Six Sigma Green or Black Belt certification preferred. Ability to effectively manage multiple priorities. Ability to analyze and interpret scientific and statistical data. Strong professional writing skills and ability to prepare technical reports. Ability to clearly articulate information during regulatory/client inspections. Ability to understand GMPs and other applicable regulatory guidelines. Strong assessment and troubleshooting skills. Computer proficiency in Microsoft Office and ability to use enterprise software. Ability to collect and analyze data and information to determine paths for process improvement and potential root cause. Demonstrated critical thinking and problem-solving skills. Working knowledge of manufacturing business acumen. Excellent written and verbal communication skills. Proficient in using Microsoft Office programs (Word, Excel, and PowerPoint). Willingness to work a flexible schedule. Able to travel for work as needed. Satisfactorily pass comprehensive background screening. Physical Demands/Working Conditions Typical work environment for a professional office or home office space and frequently works in a laboratory, supply room, and/or clean room environment. Frequent exposure to hazardous materials requiring appropriate PPE and precautions when working with hazardous materials and chemicals. Largely a stationary role with some moving from place to place. Constant use of a computer, keyboard, mouse, monitor and other office equipment. Occasional use of laboratory and manufacturing equipment. Requires some finite hand/eye coordination. Occasionally picks up, carries, and moves items up to 50 lbs. Some evening and weekend work depending upon workload. Some overnight travel will be required for work, events, and training. #J-18808-Ljbffr

Created: 2024-10-30