R&D Engineer III

Job Country:
United States (US)

Here at Avanos Medical, we passionately believe in three things:

• Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
• Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
• Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.

Here at Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future.

Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries.

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Avanos is seeking an R&D Engineer III to support the design, development, testing, documentation, and commercialization of single time use medical devices and related products across the Avanos portfolio.

The role will focus on translating product and user needs into practical engineering requirements, developing robust disposable-device designs, planning and executing engineering testing, and maintaining clear and traceable design-control documentation.

The engineer will work closely with Quality, Regulatory, Systems Engineering, Technical Operations, Manufacturing, suppliers, and external development partners throughout the product development lifecycle.

• Contribute to and lead the development of disposable and single-use medical devices, including products that interface with reusable equipment or electromechanical systems, from feasibility through commercialization.
• Translate user needs, product requirements, risk controls, and manufacturing needs into clear and measurable engineering requirements and design outputs.
• Develop and refine disposable medical device designs using sound mechanical engineering principles, including 3D CAD models, engineering drawings, component specifications, assembly specifications, and tolerance analyses.
• Apply Design for Manufacturing and Assembly principles to develop products that are reliable, cost-effective, scalable, and suitable for commercial production.
• Support material and process selection for disposable medical device components, including molded and extruded polymers, tubing, adhesives, bonding processes, films, seals, and packaging interfaces.
• Collaborate with suppliers, contract manufacturers, external test laboratories, and Technical Operations teams to evaluate manufacturability, tooling, assembly processes, process capability, production readiness, and externally generated engineering deliverables.
• Plan, execute, and document engineering testing, including feasibility, design characterization, comparative, prototype evaluation, verification, reliability, simulated-use, design-change verification, and failure investigation testing.
• Develop and review test methods, fixtures, protocols, data sheets, acceptance criteria, and test reports to ensure testing is repeatable, reliable, technically accurate, and aligned with approved requirements.
• Lead or support prototype builds, engineering builds, pilot builds, and product evaluations, including documentation of build configurations, test article conditions, component revisions, and manufacturing processes.
• Investigate prototype, design, manufacturing, and test failures using structured root-cause analysis and technical problem-solving methods.
• Generate and maintain Design History File documentation, including design inputs and outputs, specifications, drawings, design reviews, risk-management documentation, verification and validation records, traceability, engineering analyses, and design-change documentation.
• Lead or support risk-management activities, including hazard analyses, Design FMEAs, identification of risk controls, and verification of risk-control effectiveness.
• Support sterilization, packaging, transportation, shelf-life, aging, and biocompatibility activities by providing product requirements, test samples, engineering assessments, and technical documentation.
• Collaborate with Quality, Regulatory, Systems Engineering, Clinical, Marketing, Technical Operations, Manufacturing, and project leadership to ensure product and project requirements are understood and addressed.
• Mentor junior engineers in medical device design, engineering testing, design controls, technical documentation, and structured problem solving.

• Education:
  
  Bachelor’s degree in software engineering,…