Staff Plastics Engineer

Danaher Corporation•Chaska, MN

2d•Onsite

About The Position

The Staff Plastics Engineer provides 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. The role is a key technical resource for complex product development and sustaining engineering initiatives, driving robust design solutions, supplier capability, manufacturing excellence, and regulatory compliance. The position is part of the Global Hardware Engineering Organization, is located in Chaska, Minnesota, and is an on-site role. It reports to the Senior Manager, Plastics Engineering. The role may require up to 20% domestic and international travel to suppliers, manufacturing facilities, and product development activities.

Requirements

Bachelor's degree in Plastics Engineering, Mechanical Engineering, Materials Engineering, Polymer Engineering, or a 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 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 & Validation, Design History File (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 activities.

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 of critical program deliverables.
Own engineering changes across 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.
Establish, review, and maintain specifications, engineering drawings, validation protocols, technical reports, risk assessments, design history records, and other documentation required for regulatory submissions and commercialization.
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.