Manufacturing Engineer Elixir Medical - 2.9 Milpitas, CA Job Details $105,000 - $130,000 a year 19 hours ago Qualifications Project development phase management Project engineering Content creation for technical audiences Technical documentation Spreadsheets Technical writing experience within manufacturing Bachelor's degree in engineering Medical device manufacturing facility experience Compliance documentation Embedded systems programming Regulatory submissions Managing projects Biomedical manufacturing processes Technical Proficiency Stakeholder management Full Job Description 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 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.