Manufacturing Specialist

OverviewPrimary role is to insure that departmental performance standards and results are met so that company products are successfully manufactured. Initiates production builds, assembles products, troubleshoots issues as necessary, and participates in process improvement activities. Other technical and/or leadership job duties will be assigned as needed.ResponsibilitiesComply with Endologix’s policies, procedures, and quality standards as well as stretching exercises, safety and environmental regulations. Specialist in job area. (May often act as a facilitator or team leader for daily operations). Identify and report potential personnel issues to supervisor. Ensure production line training compliance and confirm that training for everyone on the line is up to date. Assemble product as required utilizing small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures. Troubleshoot manufacturing processes per documentation. Perform multiple and complex processes on the Production line with the ability to adjust priorities as needed. Demonstrate the ability to work independently on special projects as assigned. Identify and communicate any safety, quality, and process issues or concerns as needed. Maintain controlled environment integrity by using proper attire and adherence to controlled environment practices and procedures. Perform in-process quality checks as required while giving timely feedback as issues arise Recognize and report any unacceptable materials and/or sub-assemblies to engineering and/or supervisor. Responsible for 100% compliance to Endologix Quality and Regulatory policies and adhere to Endologix Core Values. Responsible for quality of work and adhering to manufacturing methods and quality records. Understand and comply with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Work with supervisors, engineers and technicians to resolve line issues and suggest improvements.Support engineering and quality in NCR investigations. Be familiar with terminology used in the production area. Provide process expertise to engineering for Continuous Improvement activities. Takes direction and gives constructive feedback easily. Capability to read and interpret engineering drawings, specs, method sheets, and/or other engineering/process documentation. Ability to redline production documentation as an input to document change orders (DCOs). Participate in lean activities and 5S improvement efforts. Lead and train others on Lean manufacturing techniques and principles. Actively pursue resolution of issues by collaborating with and utilizing all resources. Aware of common defects within manufacturing departments and the results caused by variations during the manufacturing processes. Capable of moving from one station to another without continuous mistakes Training of other production employees on manufacturing processes. Coach and provide guidance to others on manufacturing processes and standard operating procedures. Electronic systems entry. Support supervisor, as required.QualificationsHigh School Diploma or equivalent Minimum of 6 years of Manufacturing Experience (Medical Device Preferred) Work with small components, adhesives, and microscopes Experience working within a clean room environment Lean & 5S experience required Ability to read and understand manufacturing instructions and inspection procedures written in English. Ability to understand verbal instruction from supervisor, engineer Ability to effectively present information and respond to questions from managers, supervisors, engineers, auditors or visitors. Ability to work with mathematical concepts such as fractions, percentages, averages, ratios, and proportions and apply to practical situations. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Perform basic functions on a PC platform or tablet including: log-in / log-out using unique username & password, navigate to an application or internal site, perform basic data entry using a keyboard/mouse/barcode scanner/touchscreen. Strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention. Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility Actively works together with formal and informal team members to build relationships and achieve team goals Effectively prioritizes work to ensure timely completion of work within scope Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope