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 requirements
• Develop 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-budget
• Apply internal and external resources to appropriately address Manufacturing Engineering requirements
• Mentor junior engineers and technicians in the organization
• Resolve manufacturing equipment issues
• Work with the R&D team to develop and optimize manufacturing processes
• Maintain compliance with FDA and ISO guidelines for medical device development and manufacturing
• Maintain 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 implants
• Technical project management experience
• Detailed technical knowledge of processes and systems
• Experience with technical writing; TP/TR, IQ/OQ/PQ, etc., with documentation sufficient for regulatory submissions
• Knowledge of Statistics and Data Analysis
• Solid operational project management experience together with the ability to work in a collaborative environment
• Excellent communication, both verbal and written and people skills
• Advanced Excel and solid Word skills. SolidWorks is a plus
• Experience integrating automation stations, programming PLC (Arduino), computer-controlled machinery
• Experience with ERP system such as QAD, Oracle, SAP or similar is a plus
• Experience with electronic Quality Management Systems such as Arena is a plus
• BS in Engineering discipline, Master’s degree a plus