Descripción del Trabajo
This role supports manufacturing operations in process development, tool design, machine programming, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with engineering support of production. This role leads large projects that supports the technology roadmap for the site with a focus on laser etching, vision systems and automation.
- Provides direction and technical support in identifying continuous improvements to manufacturing operations and implementing new technologies including development of processes, researching current and emerging technologies and evaluating process quality, cost, capacity and capability alternatives.
- Provides direction in supporting the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
- Provides direction and technical support regarding equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving and report or presentation preparation.
- Performs assignments designed to continue the development of professional work knowledge and abilities requiring application of standard engineering techniques, procedures and criteria in carrying out a sequence of related engineering tasks, project management, statistical analysis and presentation of data and technical writing. Mentors engineering staff.
ENGINEERING DUTIES AND RESPONSIBILITIES:
- Participates in multi-site projects.
- Leads and participates in complex engineering projects around vision, laser etching and automation, either technically or with an extensive cross- functional team. This includes developing and executing to the plan and schedule and meeting the goals and objectives of the project. Tracks costs, prepares status reports, conducts meetings, and documents and communicates progress to management.
- Leads and 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). Performs analysis and communicates associated trends.
- Provides day to day support and direction to production such as, but not limited to turning, milling, drilling, EDM, finishing, laser etch, packaging etc. as required.
- Develops process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation)
- Ability to perform Measurement System Analysis on Vision Systems and OCR.
- Identifies, leads and implements process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
- Performs 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.
- Leads new equipment acquisition efforts including user requirement specifications, machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
- Develops and implements manufacturing and inspection procedures.
- Participates in and leads cross-functional teams which may include, but are not limited to Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development and other sites.
- Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.
- Identifies and implements improvements to engineering business processes such as configuration management, ERP management, maintenance tracking, etc.
- Performs other related duties, as required.
EDUCATION AND EXPERIENCE REQUIREMENTS:
- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, or a related degree.
- Master of Science Degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree, preferred.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- 4-6 years of experience in manufacturing and/or packaging engineering is required.
- Previous experience working in a regulated industry, such as Medical Device is preferred.
- Six Sigma or Lean Sigma certification or 4 years of experience preferred.
- Project Management experience
- Experience developing and implementing robust automated manufacturing equipment, preferred.
- Experience with Laser, PLC’s, PLC programming, automated systems are required.
- Controls, Sensors and wiring experiencing
- Experience with Camera Systems/OCR
- Demonstrates working knowledge of machine and electrical safety standards, preferred.
- 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, Minitab, and databases.
- Demonstrates strong organizational and project management skills and are results oriented.
- Demonstrates positive interpersonal skills and professional interactions with coworkers.
- Demonstrates troubleshooting skills.