Senior R&D Engineer, Cleaning & Disinfection

Job Title

Senior R&D Engineer, Cleaning & Disinfection

The Senior R&D Engineer for Cleaning & Disinfection (C&D) will leverage expertise in cleaning, disinfection, materials compatibility, and regulatory compliance to partner with R&D teams and ensure the safety, effectiveness, and regulatory readiness of Sleep & Respiratory Care (S&RC) products throughout their lifecycle.

• Lead the development, evaluation, and validation of cleaning and disinfection strategies for reusable and semi-reusable medical devices. Define, review, and scrutinize cleaning and disinfection requirements to ensure they are complete, risk-based, and testable.
• Plan, coordinate, and execute cleaning, disinfection, and simulated use testing with internal and external laboratories. Develop and execute test protocols, reports, and validation documentation in accordance with FDA, ISO, and global regulatory expectations. Perform hands‑on testing independently and through coordination with test technicians.
• Assess material compatibility, degradation, and functional impacts associated with repeated cleaning and disinfection cycles. Lead investigations into cleaning or disinfection‑related failures and coordinate corrective and preventive actions (CAPA) with cross‑functional teams.
• Prioritize project work and provide regular project status updates to stakeholders. Support long‑term accelerated aging and use‑life studies to assess durability and effectiveness of cleaning and disinfection processes.
• Partner with product development, risk management, toxicology, usability, and regulatory teams to ensure alignment across design, labeling, and validation. Ensure compliance with internal quality systems, including Quality System Procedures, Work Instructions, and applicable standards.
• Coordinate and participate in formal technical and design reviews to define and execute C&D strategies. Collaborate with Technical Writers to ensure Instructions for Use (IFU) and labeling accurately reflect validated cleaning and disinfection procedures.

• You’ve acquired 3+ years experience in cleaning and disinfection, reprocessing, sterilization sciences, materials compatibility, or related disciplines within medical device development. Posses strong experience in technical writing standard test protocols (STP), developing and validating cleaning and/or disinfection processes for medical devices.
• Your skills include root cause analysis, failure investigations, supporting CAPA activities; solid understanding of relevant standards and regulations, such as ISO 17664, AAMI TIR‑30, AAMI TIR‑12, ISO 10993 (as applicable), FDA guidance on reprocessing, EU MDR, and other global medical device requirements; generating technical documentation to support regulatory submissions and comfortable working hands‑on with laboratory instrumentation and test equipment.
• You have a Bachelor’s degree, required, Master’s or Ph.D. preferred in Engineering, Microbiology, Bioengineering, Materials Science, Chemistry, or a related technical discipline.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an are effective collaborator across engineering, quality, regulatory, and external testing partners and have the ability to travel up to 10% of the time.

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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