Senior Engineer - Project

We Make Life More Rewarding and Dignified

Location
:
Libertyville
Department
:
Operations

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.

• 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

• Communicate effectively via email, phone, and virtual platforms.
• Collaborate across departments to support organizational goals.
• Participate in cross-functional meetings and initiatives.
• Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
• Prepare reports and dashboards for internal stakeholders.
• Ensure data accuracy and confidentiality in compliance with company and legal standards.
• Manage multiple priorities and deadlines in a fast-paced environment.
• Lead or support special projects aligned with departmental objectives.
• Demonstrate initiative in identifying process improvements or automation opportunities.
• Serve as a point of contact for internal and external stakeholders.
• Resolve inquiries and issues with professionalism and discretion.
• Provide guidance on policies, procedures, and benefits (where applicable).
• Adhere to company policies, including those related to ADA, data privacy, and ethics.
• Maintain secure handling of sensitive information.
• Support audits and regulatory reporting as needed.
• Vision-setting and alignment with business strategy.
• High-level decision-making and resource allocation.
• Oversight of compliance, risk, and organizational culture.
• Occasional lifting of materials up to 15 pounds may be required.

• Bachelor's Degree with 5-8 years of related experience

• 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…