Staff Plastics Engineer

The Staff Plastics Engineer is responsible for providing technical leadership in the development, commercialization, and lifecycle management of injection molded plastic components, assemblies, materials, tooling, automation systems, and manufacturing processes used across Beckman Coulter Diagnostics product platforms. This role serves as a key technical resource for complex product development and sustaining engineering initiatives, driving robust design solutions, supplier capability, manufacturing excellence, and regulatory compliance while delivering innovative products that improve patient care worldwide. This position reports to the Senior Manager, Plastics Engineering and is part of the Global Hardware Engineering Organization located in Chaska, Minnesota and will be an on-site role. In this role, you will have the opportunity to: • Lead the design, development, qualification, and lifecycle support of injection molded plastic components and assemblies for diagnostic instruments, consumables, cartridges, fluidic systems, and automation platforms, serving as the plastics engineering subject matter expert on complex programs. • Lead significant technical workstreams and cross-functional project activities, including project planning, technical risk management, prioritization, stakeholder alignment, budgeting support, and execution of critical program deliverables. • Drive engineering change ownership throughout the product lifecycle, including technical assessments, risk evaluations, verification strategies, implementation planning, and change control execution across global manufacturing sites and suppliers. • Provide technical leadership for material selection, component design, mold design reviews, mold flow analysis, tooling development, process validation, troubleshooting, automation implementation, and manufacturing readiness activities to improve product performance, quality, and reliability. • Establish, review, and maintain technical documentation including specifications, engineering drawings, validation protocols, technical reports, risk assessments, design history records, and other product development deliverables required to support regulatory submissions and commercialization. • Partner with global suppliers and cross-functional teams to improve manufacturability, process capability, product quality, supply continuity, sustainability, and cost while leading root-cause investigations and continuous improvement initiatives. • Ensure compliance with applicable quality system requirements, Design Controls, risk management processes, document control procedures, and relevant FDA, ISO 13485, and international regulatory requirements throughout new product development and sustaining engineering activities. The essential requirements of the job include: • Bachelor's degree in Plastics Engineering, Mechanical Engineering, Materials Engineering, Polymer Engineering, or related engineering discipline. • 7+ years of experience in plastics engineering, injection molding, product development, tooling development, manufacturing engineering, or a related technical field. • Demonstrated experience leading the design and development of injection molded plastic components and assemblies from concept through commercialization and manufacturing scale-up. • Experience leading cross-functional engineering projects or major technical workstreams, including project planning, technical risk management, stakeholder coordination, and execution of project deliverables. • Experience working within regulated product development environments utilizing Design Controls, engineering change processes, technical documentation systems, and quality management system requirements. Travel, Motor Vehicle Record & Physical/Environment Requirements: • Ability to travel up to 20% domestically and internationally to support suppliers, manufacturing facilities, and product development activities. • Ability to work in office, laboratory, manufacturing, and supplier production environments. • Ability to occasionally lift, move, or carry materials, prototypes, tooling, or equipment up to 25 pounds. It would be a plus if you also possess previous experience in: • Medical device, in vitro diagnostics, life sciences, or other highly regulated industries. • Design Controls, Failure Modes and Effects Analysis (FMEA), Risk Management, Verification & Validation, Design History File (DHF), process validation, and Engineering Change Order (ECO) processes. • Mold flow analysis, scientific injection molding, Design of Experiments (DOE), automation systems, or global supplier development and qualification activities. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.