Provides technical support of activities related to the improvement and development of current and new processes including process cost evaluation, quality and capability alternatives analyses, and process
characterization Provides direction and supports the needs of manufacturing areas across the site to meet the requirement for quality standards, compliant documentation, capacity, product availability and cost.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Participates in engineering projects including planning and completing assigned tasks on-time and with high quality.
• Participates in investigations, develops plans and executes tasks to solve process problems including Nonconformances (NC), complaint investigations, audit observations and Corrective and Preventive Actions (CAPA).
• Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, packaging etc. as required.
• Understands existing processes, tooling setup and machine programs in order to execute tasks associated with process validation (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation) and engineering studies.
• Identifies and assists in process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies as e.g. Lean and Six Sigma principles.
• Assists in gage design, measurement system analysis, and gage implementation as required. Is able to use various types of measuring instruments including, micrometers, calipers, comparators, tensile testers, coordinate measurement systems etc. to support engineering testing.
• Develops fixtures and designs tools and has the ability to express and implement ideas with tool designers.
• Supports tasks related to new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
• Checks complex layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications, and accuracy of calculations and dimensions.
• Writes protocols and reports.
• Participates in designed experiments and capability studies as support staff, collects and maintains documents, and records process specifications.
• Is responsible for programming, set-up and debugging of complex equipment or measuring instruments.
• Collects process documentation, prepares and delivers training on processes, materials, and equipment.
• Supports and performs preventive maintenance and 5S related tasks.
• Assists in the development of manufacturing and inspection procedures.
• Participates in cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development and personnel from other sites.
• Assures adherence to all company safety policies and procedures and other safety precautions within the work area.
• Acts as a model for the operators in terms of attitude, running machines, following processes and decision making.
• Performs other related duties, as required.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is NOT directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Lean Sigma experience preferred.
• Demonstrates working knowledge of machine and electrical safety standards, preferred.
• Demonstrates troubleshooting skills.
• Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.
• Demonstrates strong written, verbal and presentation skills.
• Demonstrates strong computer skills, such as the use of Microsoft Office, CREO, Minitab, and databases, preferred.
• Demonstrates strong organizational skills and is results oriented.
• Demonstrates positive interpersonal skills and professional interactions with coworkers.
EDUCATION & EXPERIENCE REQUIREMENTS
• Associates degree, preferred. Equivalent certifications may be considered.
• 4-6 years of experience in manufacturing and/or engineering is required.
• Experience with packaging, Laser, and CNC processes, equipment and related programming software is required.
• Previous experience working in a regulated industry, such as Medical Device is preferred.
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