To provide direct engineering support to the manufacturing production lines. Ensures that the manufacturing process complies with its specifications and that the product meets material qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Conducts assignments encompassing complete projects or portions of major projects.
• Determines methods and techniques to be used or adapts standard methods to meet variations.
• Coordinate phases of work with outside vendors
• Responsible for providing technical expertise and leadership for daily manufacturing operations and ensuring established metrics (Production, Quality, Scrap and Cycle Time) are met
• Utilizes Process Excellence methodology and analytical problem solving tools to identify and implement improvement projects geared to reduce cost, eliminate scrap, improve quality and minimize cycle time
• Establishes specific manufacturing capability technology to support transfers and new product introduction
• Provides specific technical expertise to support special projects, pilot operations, product and process improvements, risk management actions and also provides input to develop capital expense forecast and equipment/spare parts budgets to support business needs
• Identifies and develops corrective action plans to improve instruments reliability in the field
• Provides support to product inquiry investigations
• Follow all company safety policies and other safety precautions within the work area
• Supports supplier evaluations for major services/products as needed
• Compliance with safety policies and procedures
• Ensures compliance with Environmental Management System (EMS) responsibilities
• Other responsibilities may be assigned and not all responsibilities listed may be assigned.
• Provides and implements robust corrective actions to quality, safety and ergonomic risk detected in the manufacturing area.
• Bilingual: English/ Spanish preferred
• GMP/ ISO knowledge preferred
• Knowledge of product and process design and development, materials, standardization science and applied statistics
• Knowledge of project management and cost analysis preferred
• Knowledge of word processing, spreadsheet analysis, data management, projects management, presentation graphics, engineering analysis and statistical software
• Knowledge of information systems including but not limited to Enterprise Resource
• Planning (ERP), Quality Systems & Documentation Control Systems
EDUCATION & EXPERIENCE REQUIREMENTS
• B.S. Engineering degree or M.S. Engineering degree
• Three to five years experience in a manufacturing environment and/ or medical device industry preferred
• Advance technical training in area(s) of expertise preferred
• Generally requires (2-4) years related experience
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