Roles & Responsibilities Manufacturing responsibility for tooling/fixtures, manufacturing equipment, and design improvements in production. Evaluate and challenge mechanism designs for reliability, functionality, and manufacturability. Provide suggested change proposals. Approve design releases to manufacturing, review engineering documentation, and provide vendor and in-house DFM inputs. Review/approve and determine the impact of ECOs from manufacturing and field perspectives. Evaluate and help in the selection of suppliers for mechanical parts if required. Help resolve supplier quality issues. Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness Document and report any variances, problems, issues, or concerns on all aspects of the manufacturing process Drive improvements in safety, quality, production, and cost. Understand, train personnel, and enforce strict adherence to the applicable Department Operating Procedures (DOPs) and Standard Operating Procedures (SOPs) of the Quality System Maintain up-to-date and accessible training records for MPIs and Quality System documents Review and disposition of discrepant material in the manufacturing line. Implement corrective actions to prevent recurrences. Active participant in quality improvement initiatives, providing feedback to find the root cause and problem-solving. Design and documentation responsibilities for custom and standard production tooling/fixtures. Skills, Experience, Education, & Training Must be a hands-on team player able to interact cross-functionally to develop improvement strategies and implement solutions. We need someone with an unfailing commitment to continuous improvement. Bachelor's in Mechanical Engineering required. 3 years of proven experience in manufacturing engineering is required. Candidates must be willing to work on the night shift (12 hrs. shift - Monday, Tuesday, Wednesday 6:00 p.m. to 6:00 a.m., and Thursday, 6:00 p.m. to 12:00 a.m.). A master's degree in Manufacturing Engineering is a plus. Strong communications skills across team organizations and cultures. Experience in ISO 13485 or a medical device manufacturing environment, is a plus. CAD experience in SolidWorks is a plus GD&T experience, must be able to interpret and read technical drawings English level B2 Upper (80% spoken) – The candidate must be capable of reading and writing technical and specialized texts, should communicate fluently within their field of expertise, actively engage in relevant discussions, and provide clear, well-reasoned explanations and arguments. Must be able to travel to the USA #J-18808-Ljbffr