Exactech
Manufacturing EngineerDepartment: Manufacturing EngineeringEmployment Type: Full TimeLocation: Gainesville, FLReporting To: Senior Manager Manufacturing EngineeringDescriptionCreate and maintain the lowest cost, highest quality machining & manufacturing processes, tooling and supporting documentation for all parts produced. Key ResponsibilitiesSupport shop floor to deliver business results while encouraging input from area personnel working within a self-directed workforce environment. Interact cross-functionally with other departments such as Quality Assurance and Design Engineering to solve manufacturing problemsExhibit ownership and take responsibility in attaining all aspects of production operation including safety, scheduling, quality, and team development in assigned areasProvide manufacturing method development and improvement for current and new productsDetermine safe manufacturing processes that produce a quality product in the most efficient method of manufacturingParticipate in the development of mid and long term plans outlining projects to support the business in meeting its objectives with a strong focus on cost, part quality and cycle timePlan and implement process-engineering activities for new product development and current product supportInvestigate and apply new technology in support of site growth plansAssist supervisors, team leads, and production employees in resolving manufacturing process problems through a drive to root cause and permanent corrective actionCo-lead efforts to maintain and improve shop floor quality controls and best practices with area team leadersPursue continuous improvement for quality and cost reductions in designated areaAct as change agent, understanding and moving the operation toward benchmarked, best of class performanceImplement manufacturing processes and execute equipment installation qualifications and process Verification/Validation studiesCreate and maintain controlled documentation for manufacturing processesUse control processes within Exactech's Change Management System and Document Change Notifications to implement process changesDevelop schedules to ensure timely completion of projects and provide input in the development of product project schedulesKnow and apply the Quality System regulations and any appropriate Federal and International standardsProvides project management leadership for the development of new products, & current vendor supplied product or processes into Exactech manufacturing operationSkills Knowledge and ExpertiseEducation:Bachelor's degree from an accredited university or college or equivalent relevant work experience required. Experience:1-3 years of Manufacturing and/or operations experience. Medical Device Industry a plus.Familiar with GMP's, and Lean Manufacturing. FDA Part 820 Quality Systems Regulations experience is a plus preferably in the medical device industryExperience in the development and execution of IQ's/OQ's/PQ documents.Knowledge of Siemens NX and Siemen Teamcenter is a plus.Understanding of geometric tolerancing and dimensioning (GD&T)Ability to create programs and design tooling for the manufacture of components from a print or model.Experience with medical device materials i.e. titanium, cobalt chrome, stainless steel, UHMWPEFunctional/Technical Knowledge, Skills and Abilities Required:Exhibits behaviors that directly align with Exactech's culture and embodies the core values of Exactech.Integrity: Exhibits honesty and demonstrates strong moral principlesAccountable: Supports teammates and delivers on actions, commitments, and projectsInnovative: Introduces new technology and listens to unsolved challenges to better develop solutions that make a real difference to processes and productsPassionate: Driven to help teammates, improve processes, and ensure product quality; help surgeons help patientsExperience with tool and fixture designs or improvementExperience in manufacturing in a regulated environmentAbility to make data driven decisions and utilize Six Sigma and Lean toolsStrong background in the interpretation of engineering drawings / specifications and manufacturing processesKnowledge of ISO / quality proceduresExcellent verbal and written communication skills