Job Overview

As a Manufacturing Engineer II, you will be a leader in improving medical manufacturing processes.  This will be a fast-paced role where you will improve yields, institute quality controls, improve process capability, and lead capital equipment projects.  You will be a key member of the team in facilitating changes with vendors and customers including management of CAPAs, Notification of Changes, Change Plans, and material qualifications. 

Job Requirements

• Lead root cause analysis using structured problem-solving methodologies.
• Drive continuous improvement in manufacturing with quality, supply chain, and operations using lean and six-sigma methodologies.
• Plan and execute engineering studies to assess manufacturing process capability, validate test methods, and validate potential process improvements.
• Collaborate with quality engineering and customers to address quality issues, design changes, and cost improvements.
• Qualify equipment for use in the manufacturing process.
• Design and implement fixtures in the manufacturing process where needed.
• Follow TE’s quality policy and comply to industry regulatory standards to ensure safe and effective use of the devices TE manufactures. 
• Attend and represent the engineering team in daily tier meetings and provide support to help solve production issues.
• Train operators, technicians, and fellow team members as needed.
• Create and modify detailed work instructions.
• Author and route Deviation Authorizations and Change Plans.

What your background should look like

• Bachelor of Science Degree in Engineering (Mechanical, Manufacturing, Biomedical or related discipline), Material Science, or other related field.
• Minimum of 3 years of engineering experience in a manufacturing environment
• Innovative idea-generator who enjoys working on diverse teams
• Structured problem-solving experience; A3, DMAIC
• Process Capability / Statistical Analysis experience (Minitab)
• Ability to effectively communicate with all levels of management, customers, and external regulatory officials.  Technical report writing and excellent record keeping required.
• IQ/OQ/PQ experience a plus
• Six Sigma, lean experience
• Catheter assembly experience a plus
• SAP experience a plus 

Competencies