Staff Plastics Engineer

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Beckman Coulter Diagnostics, one of Danaher's (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact, innovating at the speed of life.

As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making, we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

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