This position is accountable for the planning, development, design, and coordination of engineering projects and manufacturing improvements in assigned facilities. Specific accountabilities include: evaluate manufacturing processes to improve product quality, process efficiencies and machine reliability; improve workflow; validate improvements and product design.
- Manage a team of project engineers to ensure work is performed according to requirements
• Manage activities of cost reduction projects – write AFE updates and develop project timelines
• Maintaining up-to-date knowledge of validation standards and regulatory compliance requirements and independently contributes to the development of new validation standards
• Contributing to long-term strategic development of validation projects with the project engineering team
• Participate in implementing safety improvements by working with internal and external resources
• Evaluates and improves manufacturing processes by designing and conducting research programs; incorporating new methods and techniques; applying knowledge of product design, fabrication, tooling and materials; soliciting observations from operators; studying product requirements; researching, designing, modifying and testing manufacturing methods and equipment
• Assist in determining root cause and provide corrective action with customer product complaints
• Participate in projects that support in reducing downtime and scrap
• Organize, plan and commission new or modified production lines
• Investigate operational problems affecting production in a systematic and methodical manner
• Validate implemented manufacturing process improvements to ensure desired results and sustainability
• Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Responsible for the project and or work group expenditures vs. plan.
• Implements and understands FDA or regulatory requirements as necessary.
• Ensures compliance with Quality System regulations and safe working practices.
• Plans, guides, and reviews projects and or work groups under one’s control to produce the desired outcome.
• Utilizes technical skills to evaluate proposed solutions, adaptations, and modifications to projects.
- Bachelor’s Degree in engineering discipline (preferably manufacturing, mechanical or industrial engineering related)
• Minimum of 10 years work experience in Engineering, Manufacturing, and/or Quality Assurance functions preferably within high speed manufacturing
• Experience managing validation, quality, or engineering operations in a manufacturing environment
• Working knowledge of high volume manufacturing
• Strong interface skills in cross functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross functional team members
• Desired attainment of nationally recognized certification in manufacturing engineering, such as AME or SME
• Must be a self-starter with the ability to work alone, or in a team environment with limited supervision
• Excellent computer and data analysis skills. proficient in MS Office (Excel, PowerPoint, and Outlook), SAP & Data Analysis (such as Minitab) experience a plus