Manufacturing Engineer II

Erbe Elektromedizin - Tempe, AZ

Full-time - Mid Level

Tempe, AZ

About the position

The Manufacturing Engineer II position is focused on the development, documentation, qualification, and improvement of the production processes for disposable medical devices manufactured in Tempe, Arizona. As a key member of the Manufacturing team, the engineer will be responsible for identifying and implementing process improvements that enhance the efficiency and quality of assembly and production operations. This role requires a thorough assessment of current manufacturing processes, updating documentation, and pinpointing opportunities for cost reduction, time savings, and scrap minimization. In this position, the engineer will evaluate and implement changes to existing processes aimed at improving product quality, productivity, and overall equipment efficiency. Responsibilities include developing, evaluating, and refining manufacturing methods, as well as performing necessary qualification activities. The engineer will analyze workforce utilization, space requirements, and workflow to optimize the layout of equipment and workspace for maximum efficiency. Coordination with vendors to determine product specifications and arrange for the purchase of equipment, materials, or parts is also a critical aspect of the role, along with evaluating products against established specifications and quality standards. The Manufacturing Engineer II will present proposed solutions to management and other stakeholders regarding manufacturing capabilities, production schedules, and considerations that facilitate production processes. Statistical methods will be applied to estimate future manufacturing requirements and potential, and the engineer will perform verification and validation of product processes and designs. Maintaining a working knowledge of government and industry quality assurance codes and standards is essential, as is preparing and managing production documents. The role also involves revising detailed work instructions to define manufacturing and assembly processes, developing forms and instructions for quality and reliability data, and providing training and guidance to manufacturing line employees. Special projects and assignments may be assigned by the manager as needed.

Responsibilities

• Develop, document, qualify, and improve production processes for disposable medical devices.
• Identify and implement process improvements to enhance assembly and production efficiency.
• Assess current manufacturing processes and update documentation as necessary.
• Evaluate and implement changes to improve product quality, productivity, and equipment efficiency.
• Analyze workforce utilization, space requirements, and workflow to optimize equipment layout.
• Coordinate with vendors to determine product specifications and arrange for the purchase of equipment and materials.
• Present proposed solutions to management regarding manufacturing capabilities and production schedules.
• Apply statistical methods to estimate future manufacturing requirements.
• Perform verification and validation of product processes and designs.
• Maintain knowledge of government and industry quality assurance codes and standards.
• Prepare and manage production documents.
• Revise detailed work instructions to define manufacturing and assembly processes.
• Develop forms and instructions for recording quality and reliability data.
• Provide training and guidance to manufacturing line employees.
• Complete special projects and assignments as requested by the manager.

Requirements

• Bachelor's degree in engineering or science preferred, with 3+ years of related experience or training; 10+ years of experience in lieu of degree.
• Master's Degree preferred.
• Demonstrated budget management skills.
• Strong computer/IT skills required.
• Lean Six Sigma training preferred.
• Excellent verbal and written communication skills required.
• Strong facilitation and interpersonal skills required.
• Experience with statistical software programs preferred (e.g., Mini-Tab, Applied Statistics).
• Knowledge of manufacturing software, spreadsheet software, and word processing software.
• Experience with Oracle JD Edwards (JDE) EnterpriseOne and Product Lifecycle Management (PLM) preferred.
• Diverse technical background in injection molding processing, tooling, equipment, materials, manufacturing, and validations (IQ, OQ, PQ).

Nice-to-haves

• JDE/ERP experience preferred.
• Experience with SolidWorks support.