GT Medical Technologies, Inc. is hiring: Manufacturing Engineer II in Richland
GT Medical Technologies, Inc., Richland, WA, United States, 99352
Job Description
GammaTile®
The journey for a patient with a brain tumor is deeply emotional. Newly diagnosed patients often arrive at the emergency department due to changes in vision, balance, or cognitive function. Their world is quickly turned upside down as they race towards surgery. Unfortunately, many patients (~50% for glioblastomas) experience recurrence within a few months and, along with their dedicated family members and clinicians, must navigate treatment options once again. It has been over a decade since an innovative treatment option was cleared by the FDA—until GammaTile® Therapy!
GT Medical™ Technologies exists to provide a better option for these patients, caregivers, and clinicians. Guided by our Shared Values of Empathy, Empowerment, and Excellence, we strive to make a meaningful difference. Our Corporate Purpose is to Improve the Lives of Patients with Brain Tumors, and this mission drives us daily.
GammaTile® Therapy is supported by over 100 incredible teammates who collaborate organically, challenge appropriately, and are consumed with helping the next patient. With a growth rate of ~30% per year in orders, revenue, and clinical trial enrollments, our progress is encouraging, and we are aiming for even better results this year. We have a great core team, an innovative solution, and the resources to support further growth.
We are now seeking a Manufacturing Engineer II to serve our Richland manufacturing facility. If you have a heart for patients with brain tumors, the passion to improve processes, and a strong balance of engineering strategy and tactical execution, we’d love to talk to you!
Position Summary
The Manufacturing Engineer II supports the production of GammaTile device manufacturing processes and equipment. Key responsibilities or the role would be the ability to problem solve complex issues, identify areas of improvement along with associated plans and solutions to execute accordingly, have effective use of documentation and statistical techniques, and drive continuous improvement to the GammaTile platform. Serves as a coach and mentor to Manufacturing Engineer I 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.
- Provides coaching and mentoring for Manufacturing Engineer I level employees.
- Adheres to the Company’s purpose operating principles, 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.
- Minimum 5 years of experience in 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.