Manufacturing Engineer II

The primary purpose of our Manufacturing Engineer II 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 RESPONSIBILITIES:

• 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.
• Creates and implements lean processes in a cellular environment utilizing appropriate methods such as machining, welding, Finishing, Cleaning, Assembly, and Inspection.
• 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.
• 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.
• Applies DMAIC-Six Sigma approaches to solve issues and reduce variation in all manufacturing and business process
• Plans and executes project activities within a cross functional team. Project types can include new product development and introduction, manufacturing transfers, continuous improvement and cost reduction initiatives.
• 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.
• Demonstrates leadership through mentoring of peers and responsiveness to business needs to achieve positive results.
• 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.
• Knowledge of PLC programming.

Job Experience:

• 3-5  years of experience in regulated industry
• 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.