Manufacturing Engineer

GammaTile® by GT Medical Technologies, Inc.

The journey for a patient with a brain tumor is an emotional one. Newly diagnosed patients usually present in the emergency department following a change in vision, balance, or cognitive function. Their world is soon turned upside down in a race to surgery. Far too many patients (~50% for glioblastomas) recur within a few months and are forced, with dedicated family members and clinicians, to navigate treatment options yet again. Unfortunately, it has been over a decade since an innovative option has been cleared by FDA…until GammaTile® Therapy! GT Medical™ technologies exists for those patients, care givers, and clinicians who need a better option. Our Corporate Purpose is to Improve the Lives of Patients with Brain Tumors and that drives us every day.

GammaTile® Therapy is supported by 65+ amazing teammates who collaborate organically, challenge appropriately, and are consumed with assisting the next patient on the table. Our growth wave of ~50% per year for orders, revenue, and clinical trial enrollments recently produced a great validation of our execution as we closed an oversubscribed Series C round of financing in 2023. We have a great core team, an innovative solution, and the finances to support more growth. We are now in need of a Quality Assurance Technician for our Richland, WA Manufacturing Facility. If you have a heart for patients with brain tumors and a passion for engineering processes & activities, we’d love to talk to you!

Position Summary

The Manufacturing Engineer would support all engineering processes & activities in the end-to-end supply chain of the Gamma Tile medical device. The candidate would be capable of mapping all process inputs and outs within the value stream and through operational excellence tools, to be able to identify opportunities for improvement along with associated action plans and solutions to execute accordingly. The candidate would have a flexible engineering mind-set that can understand concepts and solve complex problems across a range of disciplines regardless of engineering specialty.

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/or facility as needed.
• Apply continuous improvement methods such as lean manufacturing, & value stream mapping to lead enhanced manufacturing quality, reliability, lead-time or cost-effectiveness projects.
• Identify opportunities or implement changes to improve products or reduce costs using processes, tooling, production equipment, assembly methods, quality control standards, product design, materials and parts.
• Communicate manufacturing capabilities to facilitate production processes.
• Have the ability to perform equipment qualifications (IQ), process validations (Process characterization, OQ and PQ), and gage R&R studies (TMV). Apply statistical methods and science-based decisions to design experiments and implement improvements.
• 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 good solving problem tools to recommend changes in designs, tolerances, or processes.
• Estimate costs, production times, or staffing requirements for new designs.
• Evaluate manufactured products according to specifications and quality standards.
• 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.
• Ability& proven track record to lead projects with a high degree of complexity and uncertainty.
• Embodies the Company’s operating principles, adding to 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/Requirements

• BS degree or equivalent experience in Manufacturing, Mechanical, Industrial, Chemical, Electrical or similar Engineering.
• Minimum 4 years of experience in manufacturing environment preferred, 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 and use of problem solving tools.
• 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.
• Strong interpersonal skills and ability to lead stakeholders through challenging problems whilst maintaining engagement and ensuring appropriate outcome for the business
• 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.