SR MANUFACTURING ENGINEER

Job Overview

As a Senior Manufacturing Engineer, you will be a leader in improving medical device 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. The position will support medical device manufacturing and/or extrusion processes. This role is a key member of the team in facilitating changes with vendors and customers including management of CAPAs, NOCs, Change Plans, and material qualifications. This role may be filled at a mid-level or senior level depending on qualifications and experience.

Responsibilities:

• Root cause analysis using structure problem solving methodologies.
• Drive continuous improvement activities with manufacturing engineering, quality, supply chain and operations through lean and six sigma methodologies.
• Establishing and executing, engineering studies, capability assessments, test method validations, and characterization efforts.
• Regular collaboration with customers to address quality issues, design changes, and cost improvements.
• Translating objectives (“characterize [this] output through [that] process”) into tasks and executing them.
• Equipment insourcing, improvement, and validation.
• Fixture design, development and implementation.
• Adhering to quality and compliance standards to ensure safe and effective use of the devices TE manufactures.
• Attend and represent the Engineering team in daily tiered meetings. Provide response to productions issues.
• Train and provide direction to Operators, Technicians, and fellow Team members.
• Create and modify detailed work instructions.
• Improve thermoplastic polymers processes to ensure optimized process settings.
• Author and route Deviation Authorizations and Change Plans.
• Procure & qualify capital equipment, tooling, and fixtures for manufacturing.
  

What your background should look like:

• Bachelor’s Degree of Science in Manufacturing, Mechanical, Material Science, or related field
• A minimum of 4-6 years of industry experience in a manufacturing environment
• Innovative idea-generator who enjoys leading teams and mentoring others
• Structured problem-solving experience; A3, DMAIC
• Ability to effectively communicate with all levels of management, customers, and external regulatory officials. Technical report writing and excellent record keeping required.
• Thermoplastic Extrusion/Injection molding/related experience a plus
• IQ/OQ/PQ experience a plus
• Minitab, process capability, statistics experience
• Six Sigma, lean experience
• SAP experience a plus
  

Competencies