Manufacturing Engineer I

MAIN PURPOSE OF JOB: The primary purpose of our Manufacturing Engineer I position is to apply engineering principles to drive process improvements in the manufacturing of medical devices while positively affecting quality, delivery, cost, safety and moral.  We are looking for someone with a positive attitude with excellent attention-to-detail who wants to grow professionally with high internal expectations.   MAIN JOB RESPONSIBLITIES:   Adheres to Viant Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements. Develops and Executes Process and Test Method Validations (IQ.OQ,PQ,PPQ) in accordance with Viant Medical’s procedures and guidelines. Prepares or reviews documentation with a high degree of accuracy, completeness, and effectiveness using common engineering tools and templates. (Examples include specifications, manufacturing procedures, Document Change Orders and technical reports or analysis. Communicates ideas, information, and recommendations clearly, effectively and frequently within Viant, with outside suppliers or partners and with Viant customers during formal and informal interactions. Creates and implements lean processes in a cellular environment utilizing appropriate methods such as machining, welding, Finishing, Cleaning, Assembly, and Inspection. Effectively owns and manages CAPAs pertaining to their areas of responsibility. Defines, produces and implements documents including standard work and process work instructions. Creates, reviews and approves engineering drawings, equipment layouts, change orders and specifications. Uses structured problem solving techniques and statistical methods for data driven analysis and decisions. Develops tooling, fixtures and equipment used in manufacturing to optimize productivity and cost. Creates, schedules, conducts and/or coordinates detailed project plans for engineering work. Support and participate in Continuous Improvement activities Investigates, develops and implements new process technologies using Lean Manufacturing techniques to continuously improve cycle times and process flows. Collaborates with development, programmers, machinist and suppliers to evaluate designs for manufacturability and cost reduction. Participates in cross-functional project teams to implement creative solutions. Ensure internal Viant and external customer expectations are met or exceeded. Creates and executes validation protocols, processes and material evaluations. Supports maintenance team as needed to troubleshoot equipment issues.       POSITION REQUIREMENTS:   Close vision, distance vision, color vision, etc. to inspect parts, blue prints. Experience in medical devices preferred. Statistical knowledge and understanding of metals machining and polishing is preferred.   Good problem solving skills. Strong written and oral communication skills. Ability to work in a team environment. Must be able to work with minimum supervision. Knowledge/Education: Engineering or Bachelor’s degree in a technical field with applicable experience Proficient in Microsoft office suite (word, excel, outlook) Demonstrated proficiency in Solid Works and Minitab preferred.     Job Experience: 0-3  years within Regulated Industry, preferred Lean manufacturing and new product development or launch support experience is highly desirable.    Physical Requirements: Light work: Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects.