Summary of Major Responsibilities
The Industrial Engineer leads collaboration efforts with internal and external stakeholders to specificity, procure, install, commission and maintain equipment, as well as implement processes to further streamline manufacturing and equipment operations. The manufacturing systems & equipment includes, but not limited to, the diagnostic kits, fill-cap-label machines and material handling systems. The Industrial Engineer will also track and monitor performance of the manufacturing line and automated systems and may serve as a technical expert to support supply chain relationships with contract manufacturing partners and vendors. Additionally, this person will also be responsible for system improvements and optimization of production operations to improve throughput and increase efficiency as well as supervision of maintenance, repair, service, monitoring and programming of automated production components and systems for Exact Sciences Corp. and Exact Sciences Laboratories. This role will provide superior project management services for assigned projects.
Essential Duties and Responsibilities
- Based on stakeholders’ input and in collaboration with internal and external partners will conceive, specify, procure and implement engineering controls installation and modifications to support new manufacturing solutions, process.automation/improvement, clinical laboratory test procedure automation, volume growth and new product introduction.
- Support existing automation installations including implementation of new products, hands-on troubleshooting, equipment set up and adjustment, repair, planned maintenance and performance monitoring.
- Lead projects to analyze, troubleshoot and improve processes, including manual and automated/semi-automated reagent formulation, dispensing, labeling and packaging in a cGMP environment and/or clinical laboratory diagnostic sample testing automation in a CAP/CLIA environment.
- Provide support to production/operations, which includes, recommending and assisting with design changes to improve manufacturability as appropriate.
- Reduce product build costs and component cost as well as support the selection and qualifying of vendors/suppliers.
- Support critique of part designs guide appropriate dimensioning and select critical to function elements of design to drive robust Design for Manufacturability.
- Participate in tool design reviews to ensure robust mechanical design, longevity of tooling and optimum molding performance.
- Trouble-shoot tooling and process issues with established platforms.
- Engage on activities with external suppliers, molders, tool makers and material suppliers.
- Seek new and better technologies and methods to increase product performance, add features and reduce component and production costs.
- Assist with investigation around product failure and work closely with vendors to determine root cause of product failure modes and implement corrective actions.
- Maintain detailed 3D models, create assemblies, technical drawings, testing reports and information packets that effectively communicate design intent using CAD (specifically SolidWorks).
- Develop and maintain documentation (standard operating procedures, user requirements, design specifications, component specification and selection, commissioning protocols, etc.) necessary to ensure consistent, high-quality projects.
- Provide technical support, ensuring appropriate change control practices are followed for manufacturing processes.
- Lead or participate in investigations and troubleshooting of manufacturing processes associated with internal review, CAPA, audits or complaints.
- Collaborate with R&D and Operations/Lab Operations to ensure design for manufacturability elements are incorporated into product requirements and development activities to facilitate smooth transfer of products and processes into new or existing automation systems.
- Lead or support new equipment specification, design, installation, commissioning and qualification activities.
- Carry out other duties, responsibilities, and projects as may be assigned, in an effective manner.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work nights and/or weekends.
- Ability to work normal schedule of Monday through Friday during normal business hours.
- Ability to lift up to 50 pounds for approximately 10% of a typical working day.
- Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 20% of a typical working day.
- Ability to work in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to comply with any applicable personal protective equipment requirements.
- Ability to travel approximately 10% of working time.
- Bachelor of Science in Mechanical or Industrial Engineering, or related technical field.
- 5+ years of work experience in a plastic molding or medical device manufacturing environment.
- 3+ years in Industrial manufacturing experience working in high-volume injection molding.
- Experience in the qualification of complex, tight tolerance injection molds.
- Project management skills.
- Excellent problem-solving skills using DMAIC methodology.
- Solid communication skills and ability to communicate effectively across all organizational levels, as well as with external suppliers.
- Solidworks 3D modeling and drafting skills.
- Authorization to work in the United States without sponsorship.
- Working knowledge of statistical techniques, problem solving techniques and quality management systems.
- Knowledge of quality tools such FMEA, Root-Cause-Analysis, Corrective Actions, and various Taguchi techniques.
- Knowledge of statistical methods (6 Sigma, SPC, DoE).
- Experience working in a cGMP / ISO 13485 compliant manufacturing environment.
- Experience with commercialization of new product.
- Experience with automated production equipment.