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Project Leader IV
12 Month Contract
This role supports manufacturing operations in the areas of process development, packaging, machinery & equipment acquisition, manufacturing layout, continuous improvement and other duties associated with engineering support of production.
• 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 compliance documentation, capacity, product availability and cost to meet business goals.
• Leads initiatives to develop and enhance packaging and labelling capabilities within the business through liaising with design functions and other industry forums to implement best practice.
• 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.
• Leads and participates in highly complex engineering projects, either technically or with an extensive cross-functional/ multi-site 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.
ENGINEERING DUTIES AND RESPONSIBILITIES:
• Identifies, recommends and implements transformational process opportunities within and across sites. Leads or participates in such projects.
• Identifies, recommends and implements standardization of processes across the business.
• Leads and participates in complex investigations, develops plans and executes tasks to solve process problems including Non- conformances (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, packaging etc. as required.
• Develops process validation strategy for complex processes 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).
• Identifies, leads and implements transformational process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies such as, Lean and Six Sigma principles.
• 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, personnel from other sites and external resources.
• 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.
• Participates or leads internal or external technical committees in the development of standards related to manufacturing such as processes, DFMA, equipment, testing.
• Performs other related duties, as required.
• Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial 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:
• 6+ years of experience in manufacturing and/or engineering is required with minimum 1 year in a leadership role.
• 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.
• Experience developing and implementing robust automated manufacturing equipment, preferred.
• Experience with packaging, Laser, and CNC processes and equipment, preferred.
• 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 with ability to communicate to senior stakeholders.
• Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
• Demonstrates strong organizational and project management skills with experience in MS Project (or similar platform) and are results oriented.
• Demonstrates positive interpersonal skills and professional interactions with coworkers.
• Demonstrates troubleshooting skills.
• Must be willing to support global projects including some travel.
• Must be willing to support all production shifts.
• May be responsible for the supervision and / or hiring of Engineering Technicians or Interns.
• Participates in and understands compliance related activities pertaining to the job assignment including compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
• Follows all laws and policies as they apply to one's job and maintains the highest levels of professionalism, ethics and compliance at all times.
• Supports and operates in a proactive safety environment
• Works in conditions that may be hot, cold, wet and/or noisy along with exposure to fumes, oil, coolants and other manufacturing related chemicals.
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.