Staff Plastics Engineer

Danaher•Chaska, MN

1d•Onsite

About The Position

The Staff Plastics Engineer provides technical leadership in developing, commercializing, and managing the lifecycle of injection-molded plastic components, assemblies, materials, tooling, automation systems, and manufacturing processes across Beckman Coulter Diagnostics product platforms. The role is a technical resource for complex product development and sustaining engineering initiatives, advancing robust designs, supplier capability, manufacturing excellence, and regulatory compliance. The position is part of the Global Hardware Engineering Organization, is based in Chaska, Minnesota, and is on-site. It reports to the Senior Manager, Plastics Engineering. The position leads plastics engineering activities for diagnostic instruments, consumables, cartridges, fluidic systems, and automation platforms. It also provides technical leadership across materials, component and mold design, tooling, process validation, automation, manufacturing readiness, engineering changes, and lifecycle support. The engineer partners with global suppliers and cross-functional teams to strengthen manufacturability, quality, supply continuity, sustainability, and cost, while supporting compliant product development and commercialization. The role may require domestic and international travel of up to 20%. Work may take place in office, laboratory, manufacturing, and supplier production environments. Occasional lifting, moving, or carrying of materials, prototypes, tooling, or equipment weighing up to 25 pounds is required.

Requirements

Bachelor's degree in Plastics Engineering, Mechanical Engineering, Materials Engineering, Polymer Engineering, or a related engineering discipline.
At least 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 delivery execution.
Experience in regulated product development environments using Design Controls, engineering change processes, technical documentation systems, and quality management system requirements.
Ability to travel up to 20% domestically and internationally.
Ability to work in office, laboratory, manufacturing, and supplier production environments.
Ability to occasionally lift, move, or carry materials, prototypes, tooling, or equipment weighing up to 25 pounds.

Nice To Haves

Experience in medical device, in vitro diagnostics, life sciences, or another highly regulated industry.
Experience with Design Controls, Failure Modes and Effects Analysis (FMEA), Risk Management, Verification and Validation, Design History Files (DHF), process validation, and Engineering Change Order (ECO) processes.
Experience with mold flow analysis, scientific injection molding, Design of Experiments (DOE), automation systems, or global supplier development and qualification.

Responsibilities

Lead design, development, qualification, and lifecycle support for injection-molded plastic components and assemblies used in diagnostic instruments, consumables, cartridges, fluidic systems, and automation platforms.
Serve as the plastics engineering subject matter expert on complex programs.
Lead significant technical workstreams and cross-functional project activities, including planning, technical risk management, prioritization, stakeholder alignment, budgeting support, and delivery execution.
Own engineering changes throughout the product lifecycle, including technical assessments, risk evaluations, verification strategies, implementation planning, and change control 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.
Establish, review, and maintain specifications, engineering drawings, validation protocols, technical reports, risk assessments, design history records, and other product development documentation.
Partner with global suppliers and cross-functional teams to improve manufacturability, process capability, product quality, supply continuity, sustainability, and cost.
Lead root-cause investigations and continuous improvement initiatives.
Ensure compliance with quality system requirements, Design Controls, risk management processes, document control procedures, and applicable FDA, ISO 13485, and international regulatory requirements.