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
• Follow Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
• 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.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job may be directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• 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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