Manufacturing Engineer III

About the Role

As a Manufacturing Engineer, you will be responsible for improving manufacturing processes, supporting production operations, and ensuring products are produced safely, efficiently, and in compliance with quality and regulatory requirements. This role serves as a key link between engineering, production, quality, and suppliers to drive continuous improvement and operational excellence.

Job Responsibilities

• Follow all manufacturing Good Manufacturing Practices (GMP's) as defined by Viant Medical's practices, policies and Standard Operating Procedures (SOP's)
• Performs project management responsibilities for assigned manufacturing changes or new product methods, designs of production fixtures, and methods to monitor efficiency
• Evaluates existing machinery and processes to recommend improvements that enhance both operator performance and ergonomics/safety of overall production
• Optimizes floor layout, material flow, along with implementation of lean concepts; document improvements to manufacturing efficiencies, takt time, floor space utilization and overhead
• Develops or revises technical documentation to specify manufacturing processes; including documentation of equipment qualification, setup and maintenance procedure
• Conducts research and development testing and validation to determine effectiveness and compliance to quality standards for the manufacturing processes
• Confirms conformance to engineering designs and methodologies and verify overall safety and prepares reports on these activities
• Confers with vendors to determine product specifications and arrange for purchase of equipment, materials, or parts, and evaluates products according to specifications and quality standards
• Utilizes proven lean manufacturing based analytical and troubleshooting/problem solving abilities to identify opportunities for cost reduction, lead-time reduction, inventory reduction and quality improvement through defect reduction
• Performs other duties as needed

Education/Experience

• Minimum 3 years of experience in the medical device industry or another regulated manufacturing environment
• Minimum 2 years of experience supporting new product development and quality engineering activities
• Experience with metal processing
• Minimum 2 years programming & hands on problem solving knowledge of machining
• Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical or scientific field, or equivalent combination of certification and experience
• CQE certification is a plus
• Experience with FDA regulations, ISO 13485, and quality management systems preferred

Competencies

• Strong knowledge of quality engineering principles, including SPC, FMEA, DOE, process validation, root cause analysis, and CAPA methodologies
• Proficient in statistical analysis, Microsoft Excel, Minitab, and measurement system evaluation techniques
• Skilled in supplier quality management, qualification processes, audits, corrective actions, and continuous improvement initiatives
• Working knowledge of Lean Manufacturing and Six Sigma methodologies
• Strong analytical, troubleshooting, and problem-solving capabilities
• Excellent verbal and written communication skills with the ability to deliver training and collaborate across cross-functional teams
• Effective project and priority management skills with the ability to work independently in fast-paced manufacturing environments