Manufacturing Engineer II

The role

The Manufacturing Engineer will work with the Product Development Team and outsourced suppliers to create, improve, implement and document processes for manufacturing, packaging and labeling products. This role involves designing supply chain manufacturing processes, supporting change controls, and managing supplier sourcing.

What you will do

• Perform supplier sourcing, evaluation and management
• Create and maintain documentation of tool drawings, design concepts and orders
• Collaborate to design and develop supply chain manufacturing processes
• Support Engineering Change Notice (ECN) and Material Review Board (MRB) activities
• Participate in project validation phases and transition to manufacturing operations
• Participate in cross-functional teams for product packaging, testing, validations and labeling
• Assist in the evaluation of returned materials/products
• Support and adhere to company policies, procedures, goals and objectives
• Support the SI-BONE Quality System
• Travel to supplier facilities to observe and evaluate manufacturing and assembly processes

Required qualifications

• Bachelor’s Degree in Manufacturing Engineering or Mechanical Engineering
• Minimum of 4 years’ manufacturing engineering experience, with specific experience in medical devices/components
• NPI and product launch exposure
• Experience drafting manufacturing change documents
• Microsoft Excel, Microsoft Access, Microsoft Project, CAD, SolidWorks, Minitab, and ERP systems (QAD)
• Experience working in a dynamic medical device manufacturer and/or contract medical device manufacturer
• Experienced in designing, analyzing, acquiring and qualifying manufacturing tools and equipment
• Familiar with statistical tools and concepts such as ANOVA and DOE methods
• Knowledge of FDA and functional requirements for sterile, non-sterile, disposable and reusable devices
• Excellent time management skills
• Ability to prioritize workload with minimal supervision
• Ability to network and interact effectively with a broad range of associates

Nice to have

• Strong knowledge of manufacturing technologies for Class I and II medical devices, specifically in the orthopedic and implantable space
• Experience in multiple roles and responsibilities conducive of a company in a current state of product development and maturation

About the company

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions.