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. Requires detailed technical knowledge of processes and systems. Must be able to 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

• Minimum 5 years relevant experience in medical device industry Manufacturing Engineering (ME); preferably including Class III implants
• Technical project management experience. Some experience managing engineers is a plus
• 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

EDUCATION REQUIREMENTS

• BS in Engineering discipline, Master’s degree a plus