Senior Engineer Jobs in Pleasant Prairie, WI (NOW HIRING)

The Senior Engineer applies engineering expertise, technical judgment, and project management discipline to ensure manufacturing equipment, processes, and systems are ready to support the successful commercialization of new Class I medical devices, primarily ostomy products. This role is responsible for the development, procurement, installation, qualification, and startup of manufacturing equipment and processes while identifying and resolving technical challenges that could impact product launch readiness. The Senior Engineer collaborates closely with R&D, Operations, Quality, Supply Chain, and external suppliers to support design transfer, process validation, capacity planning, and risk mitigation activities. Working under general supervision, this role drives execution of capital project budgets, evaluates manufacturing performance and process capability, and provides clear communication of project status, risks, and recommendations to stakeholders and leadership to ensure safe, compliant, and timely product launches.

• Lead or support complex engineering projects with a focus on developing and qualifying manufacturing equipment and processes for the launch of new products.
• Serve as the technical lead for film/web handling, component feeding and placement, and heat-sealing technologies, driving equipment selection, process development, validation, troubleshooting, and performance optimization to meet quality, capacity, and commercialization objectives.
• Establish and maintain the "Voice of the Process" by identifying critical process inputs and outputs, defining process capability requirements, and utilizing data-driven methods to ensure consistent manufacturing performance and product quality.
• Coordinate cross-functional activities to ensure timely execution of equipment trials, process development, validation, and manufacturing readiness milestones while proactively resolving issues that could impact project timelines.
• Apply engineering principles, structured problem-solving methods, and project management practices to achieve project objectives.
• Prepare and maintain technical documentation, specifications, engineering reports, project updates, and related records.
• Support project planning activities, including resource requirements, budgets, vendor engagement, and project schedule adherence.
• Communicate technical findings, project status, risks, and recommendations to stakeholders and leadership via written reports, digital communications, and presentations.
• Ensure project alignment with applicable quality, safety, regulatory, engineering, and company standards.

Technical Expertise

• Design transfer and New Product Commercialization for medical device manufacturing
• Film/web handling systems, injection molding, converting equipment
• Component feeding, registration, and placement technologies
• Heat sealing and material converting processes
• Capital project execution and equipment qualification in medical device manufacturing
• Automated manufacturing equipment and controls (vision system, robotics)
• Computer Aided Design software knowledge, tooling and part design and file management (product lifecycle management)
• Process characterization, validation, and capability analysis
• Statistical data analysis and process monitoring

• Bachelor's degree in Engineering or a related technical field.
• Experience in engineering, technical project execution, problem solving, lean manufacturing and continuous improvement.
• Experience leading or supporting cross-functional and multi-site projects.
• Demonstrated ability to analyze data, solve technical problems, and implement effective solutions.
• Working knowledge of project management principles and practices.
• Ability to communicate technical information effectively to technical and non-technical audiences.
• Experience in production environment, medical device preferred
• Travel up to 25% of the year to domestic and international production sites
• Tooling and equipment design and fabrication