Add value through knowledge about process engineering; supports stabilization and the continuous improvement projects life cycle since its identification to the execution and closure in terms of cost, quality, efficiency and time cycle. Rapid response to operations in: technical resolution, direction change, manufacturing scalability, process/product development and replacing materials. Completes projects within the site or with suppliers, to provide an uninterrupted flow of components for assembly operations that meet instrument, quality, cost, and delivery requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Must know and follow rules, policies and procedures of the company that are related with work activities within responsibility area, must assure that the subordinates know and follow same rules, policies and procedures.
• Complete training in responsibility area, within the time assigned. Training is required for changes and implementation of policies, existing procedures, new functions, etc. Complete retraining required in areas such as Safety and Environment.
• Follow all safety policies of the company and all the safety measures within work area.
• Promote Safety work environment to all workplace associates.
• Responsible for leading and executing projects focused in the variation reduction originated by process and/or design of the product that positively influences in the business metrics, strategic direction and financial results.
• Keep work plans through the year, such as change in base product design (product line extension), process changes and cost improvement projects.
• Identify and execute supply chain manufacturing and/or suppliers cost improvement projects.
• Lead technical projects within manufacturing site or suppliers to improve process capacity, capability, yield and maintainability.
• Provide technical support for the approval/ validation of changes/ improvements within manufacturing site or supplier processes
• Provide technical support for the resolution of component quality issues
• Potentially perform supervision functions in ME technical areas (PROJECTS/CAD/BOM).
• Sustain supply chain continuity by qualifying and validating site and/or supplier tooling as per component approval procedures.
• Ensures closure to component non-conformance issues with timely corrective action submission and approval of site and/or suppliers control plans.
• Other responsibilities may be assigned and not all responsibilities listed may be assigned Will have responsibility for multiple components or mfg. processes of moderate complexity on the development/revision of a product.
• May serve as lead Operations engineer on a development/revision of a product of moderate complexity, or have responsibility for multiple components or mfg. processes of significant complexity on the development/revision of a product. May contribute critical expertise across multiple product lines.
• May be responsible for direction and development of technical support staff. Plans, conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field. Applies comprehensive and diverse knowledge of engineering principles and practices within broad assignment areas.
• May coordinate and direct activities of technical support staff and may be responsible for, technical development of assigned staff
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Bilingual English/Spanish
• Group integration, multifunctional tasking and coordinates collaboration between multiple functional groups.
• Effective communication, oral, written and for presentations.
• Project management, lead teams located in different areas while executing a Project.
• Technical competencies, preferred
• Tool design
• Product/Process risk evaluation
• Cleaning Validation
• Design and automation of equipment
• Interplant transfers
• Design and validation of proof methods
• Lean and Six Sigma skills
• Process validation
• Design validation and verification
• Operations management
• Technical process writing
• Regulatory knowledge
• Plastic molding injection
• Technical skills, preferred:
• Plastic processing
• Mechanical and electrical skills
• Process Characterizations
• Polymer knowledge
• Chemical processing
• Electrical, Electronics and PLC
• Assembly and equipment process development
• Metrology and calibrators development
• PLC (troubleshooting)
• Credo acting values and behavior
• Company Process and product knowledge
• Quality system knowledge
• GMP/ ISO knowledge
• Computer skills
• Proficient in Word processing, spreadsheets, presentations and database applications.
• Statistical analysis software
• Engineering software (FEA, CAD, etc) as it applies.
• Other skills may be required and not all skills listed may be utilized.
EDUCATION & EXPERIENCE REQUIREMENTS
• Bachelor of Science in Engineering
• Technical formation preferred
• Advanced Degree in Science or Engineering preferred
• Masters or PHD preferred
• 4 - 6 years of experience in a product development and/or manufacturing environment
• Experience in medical product industry is preferred.
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