R&D Engineer III

About the role

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.

Responsibilities

• 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.

Qualifications

• Required Education: Bachelor’s degree in software engineering, Computer Engineering, or a related technical discipline. 8-10 years of architecture, technical design and software development experience
• Demonstrated ability to deliver results while working on multiple projects simultaneously, balancing resources, timing and quality of outcomes.
• Demonstrated competency in understanding and defining the functionality of complex systems and the interactions and dependencies in the HW and SW sub-systems
• Experience reviewing software requirements, system requirements, design documentation, test documentation, and traceability records.
• Strong understanding of requirements management and traceability between requirements, design outputs, risk controls, verification testing, and validation evidence.
• Hands-on experience with secure boot implementation and firmware upgrade mechanisms, including secure and reliable update processes.
• Strong knowledge of operating-system kernels and bootloaders, including configuration, integration, debugging, and troubleshooting.
• Strong technical writing skills with the ability to create and review clear, complete, accurate, and well-organized technical documentation.
• Strong communication skills with the ability to work effectively with internal teams, external development partners, and cross-functional stakeholders.
• Experience working in a cross-functional, matrixed product-development environment.

Preferred Experience

• Experience developing products involving fluid delivery, tubing sets, connectors, valves, pumps, catheters, feeding products, pain-management products, or other disposable medical device systems.
• Experience designing disposable products that interface with reusable equipment, electro-mechanical devices, or capital equipment.
• Experience with medical-grade polymers, material selection, injection molding, extrusion, adhesives, joining methods, and high-volume assembly processes.
• Experience with test method validation, Gage R&R, measurement-system analysis, Design of Experiments, reliability testing, or statistical sample-size determination.
• Experience using statistical-analysis software such as Minitab, JMP, or equivalent tools.
• Experience supporting sterilization activities using ethylene oxide, gamma, or e-beam methods.
• Familiarity with packaging validation, transportation testing, accelerated aging, shelf-life testing, and sterile barrier systems.
• Familiarity with biocompatibility assessment and biological evaluation activities.
• Familiarity with applicable medical device regulations and standards, including: ISO 13485, ISO 14971, ISO 10993, IEC 62366, where applicable, FDA medical device design-control requirements
• Experience supporting usability, simulated-use, or product-validation activities.
• Experience collaborating with contract manufacturers, external design firms, component suppliers, or independent test laboratories.
• Experience supporting design transfer, manufacturing qualification, process validation, or commercialization.
• Experience with requirements-management, product-lifecycle-management, or quality-management systems such as Jama, Polarion, Windchill, Arena, Agile PLM, or similar platforms.
• Participation in invention disclosures, intellectual-property development, or patent applications.
• Six Sigma, Design for Six Sigma, project management, or related certification is a plus.