Manufacturing Engineer

MAJOR DUTIES AND RESPONSIBILITIES Responsibilities will include, but not be limited to:Senior technical resource for processes, systems, and equipment for Manufacturing Engineering at Elixir.

Develop new processes, optimize existing processes and systems, and design for future requirementsDevelop Manufacturing Engineering projects to improve quality, capacity, and cost.

Lead cross-functional stakeholder groups for projects.

Analyze benefits vs investment for initiatives.

Manage projects and resources from initiation to implementation on-time and on-budgetApply internal and external resources to appropriately address Manufacturing Engineering requirementsMentor junior engineers and technicians in the organizationResolve manufacturing equipment issuesWork with the R&D team to develop and optimize manufacturing processesMaintain compliance with FDA and ISO guidelines for medical device development and manufacturingMaintain compliance with all document and procedure training requirements QUALIFICATIONS Experience & Education Minimum 5 years relevant experience in medical device industry Manufacturing Engineering (ME); preferably including Class III implantsTechnical project management experienceDetailed technical knowledge of processes and systemsExperience with technical writing; TP/TR, IQ/OQ/PQ, etc., with documentation sufficient for regulatory submissionsKnowledge of Statistics and Data AnalysisSolid operational project management experience together with the ability to work in a collaborative environmentExcellent communication, both verbal and written and people skillsAdvanced Excel and solid Word skills.

SolidWorks is a plusExperience integrating automation stations, programming PLC (Arduino), computer-controlled machineryExperience with ERP system such as QAD, Oracle, SAP or similar is a plusExperience with electronic Quality Management Systems such as Arena is a plusBS in Engineering discipline, Master’s degree a plus