ELIXIR MEDICAL CORPORATION
Responsibilities
- 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 and Skills
- 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
Education Requirements
- BS in Engineering discipline, Master’s degree a plus
This position is based in Milpitas, CA and is an onsite position. The salary range is $105K to $130K based on factors including experience, skills, etc.
#J-18808-Ljbffr