R&D Engineer III - Alpharetta, GA

Requisition ID: 7258

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. 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. For more information, visit www.avanos.com.

Essential Duties:

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.

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

Bachelor’s degree in mechanical engineering, Biomedical Engineering, or a related engineering discipline.

5-7 years of experience in medical device design and development or a related regulated product-development environment.

Experience developing disposable, single-use, or polymer-based medical devices or comparable regulated products.

Demonstrated experience supporting or leading design activities for Class II or Class III medical devices.

Experience taking products or components through multiple phases of the product development lifecycle.

Experience developing and maintaining Design History File documentation, reviewing engineering requirements, specifications, drawings, risk documentation, test protocols, test reports, and traceability records.

Hands-on experience planning and executing engineering characterization, design verification, reliability, or simulated-use testing.

Experience developing test methods, test fixtures, acceptance criteria, and data-collection approaches.

Experience investigating design, prototype, manufacturing, or test failures and documenting root-cause conclusions.

Experience working in a cross-functional, matrixed product-development environment.

Position is based in Alpharetta, GA with the ability to work at least three days a week (ideally Tuesday-Thursday) in office and be available for onsite workshops when required.

Preferred Qualifications:

• 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.

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law.

IMPORTANT: If you are a current employee of Avanos or a current Avanos Contractor, please apply here.

Join us at Avanos

Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world.

Make your career count

Our commitment to improving the health and wellbeing of others begins with our employees – through a comprehensive and competitive range of benefits. We provide more than just a salary – our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. Avanos also offers the following: benefits on day 1 free onsite gym onsite cafeteria HQ region voted 'best place to live' by USA Today uncapped sales commissions.