Elixir Medical

Senior Manufacturing Engineer Job at Elixir Medical in Milpitas

Elixir Medical, Milpitas, CA, United States

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