Manufacturing Engineer II (Medical Device) - Coyote Technical & Executive Sourcing

Work with engineering director to determine projects and related tasks

• Refine manufacturing processes and flow
• Develop new processes that increase productivity and reduce cost
• Implement cost reductions via materials or manufacturing time
• Investigate and provide engineering support to Manufacturing processes, SPC, and non-conforming material (NCR)
• Prepare, analyze, and present data at monthly NCR and Management Review meetings (if applicable)
• Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable)
• Manage duties of engineer/technician/intern, including workload and personal issues (if applicable)
• Complete investigation, improvements, and documentation of preventative and corrective actions (CAPAs)
• Utilize Lean Manufacturing principles in order to increase productivity / throughput, reduce cost, and /or eliminate waste
• Implement new processes and issue process validation protocols and reports
• Develop, document (using AutoCad / SolidWorks), and implement fixtures, jigs, tools, and gages
• Document methods for manufacturing and inspection (Manufacturing Instructions)
• Work with Research and Development and Process Development to develop and transfer new designs to manufacturing (lead and manage design transfer projects)
• Initiate process, design, and documentation changes through the change management process
• Utilize statistics to evaluate, justify, and support experiments, analysis, and validations
• Log engineering evaluations into Engineering Notebooks
• Perform tooling verifications and carry out IQ/OQ/PQ activities
• Perform Root Cause Investigations, develop and implement solutions
• Perform process development and execute DOE’s (Design of Experiments)
• Work with Mfg Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis

Qualifications

• Excellent written and verbal communication skills
• Proficient in software applications
• Ability to organize and conduct experiments independently
• Ability to analyze and solve technical problems
• Hands on abilities to engineer tooling, processes, and equipment
• Hands on experience building prototypes, tooling, and fixtures
• Bachelor’s degree in engineering or equivalent experience
• 5+ years of experience in an engineering role in the medical device industry
• Project management experience in the medical device industry
• Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes
• Experience with polymers, medical grade metals, manufacturing equipment, and medical packaging