Manufacturing Engineer

About Scientia Vascular Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients. Position Summary Identify, support and manage process development and continuous improvement initiatives in a manufacturing environment. Responsible for providing expert daily direction in set-up, troubleshooting, repair, and continuous improvement of production equipment. Resident expert on production equipment and processes and provides education to engineers, manufacturing, and maintenance personnel to ensure efficient product processing. Contributes to cross-functional development teams through risk analysis, process development, and project management. This position will work under general direction and have latitude in determining how to solve problems. Primary Responsibilities Provides daily direction and support to manufacturing to support assembly cells. Interface with production personnel to actively troubleshoot production problems as well as continually improve processes. Maintains control of component and tooling implementation for production, including but not limited to equipment validation, component drawings and device bill of material. Provides expertise in specification, procurement, build, documentation, validation, and personnel training on manufacturing equipment. Ensures processes and procedures are in compliance with regulations. Identify opportunities and implement solutions for process improvements and cost savings consisting of new methodologies, materials, machine processes, or products. Apply appropriate technical skills and tools, such as DOE, hypothesis testing, capability studies, and lean manufacturing tools, to perform in depth analysis, determine root cause, and identify corrective actions. Manage projects and communicate status and challenges to key stakeholders. Other duties as assigned with or without accommodation. Requirements Minimum BS in Engineering Minimum of 1 year experience Medical device manufacturing experience preferred Experience with medical device design controls preferred Strong written and oral communication skills Familiarity with data analysis and statistical methods SolidWorks experience preferred Mechanical aptitude/troubleshooting Lean & 6-sigma experience preferred Proficiency with Microsoft Excel and Word Key Benefits We Provide Medical, Dental, Vision insurance Generous Paid Time Off (PTO) Paid Parental Leave Paid Holidays 401k Plan (with a generous employer match) Life Insurance (company paid) Short-Term & Long-Term Disability Insurance (company paid) Subscription to Calm.com Employee Assistance Program An environment of belonging where everyone can thrive Commitment To Equal Opportunity The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture, all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, family status, marital status, sexual orientation, national origin, genetics, disability, age, or veteran status, or any other non-merit based or legally protected grounds. #J-18808-Ljbffr