R&D Engineer, Cleaning & Disinfection

Philips • New Kensington, PA

5d • Onsite

About The Position

R&D Engineer, Cleaning & Disinfection
The Cleaning & Disinfection (C&D) Engineer will support the development and validation of cleaning and disinfection processes by applying technical knowledge of reprocessing, materials compatibility, and regulatory requirements. You will partner closely with R&D and cross-functional teams to help ensure the safety and effectiveness of Sleep & Respiratory Care (S&RC) products throughout their lifecycle.

Requirements

• You’ve acquired minimal experience in cleaning and disinfection, reprocessing, sterilization sciences, materials compatibility, or a related area within medical device development, preferred as well as experience executing or supporting cleaning and/or disinfection validation testing.
• Your skills include working knowledge of root cause analysis, failure investigations, CAPA activities, and hands-on laboratory testing using various instruments.
• You’re also familiar with key standards and regulations (ISO 17664, ISO 10993, FDA reprocessing guidance, EU MDR) and have contributed to technical documentation for regulatory submissions.
• You have a Bachelor’s degree, required in Engineering, 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 are able to travel up to 10% of the time and can collaborate effectively with engineering, quality, regulatory, and external testing partners.
• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• For this position, you must reside in or within commuting distance to New Kensington, PA.

Responsibilities

• Support the development, evaluation, and validation of cleaning and disinfection processes for reusable and semi-reusable medical devices.
• Review and help refine cleaning and disinfection requirements to ensure they are clear, risk-based, and testable.
• Execute cleaning, disinfection, and simulated use testing in collaboration with internal teams and external laboratories.
• Author and support test protocols, reports, and validation documentation in alignment with FDA, ISO, and global regulatory requirements.
• Perform hands-on laboratory testing independently and with support from test technicians.
• Evaluate material compatibility and durability impacts associated with repeated cleaning and disinfection.
• Assist with accelerated aging and use-life studies to assess cleaning and disinfection durability.
• Participate in technical and design reviews related to cleaning and disinfection strategies.
• Support investigations into cleaning or disinfection-related issues and contribute to root cause analysis and CAPA activities.
• Manage assigned project tasks and provide regular status updates to project and functional stakeholders.
• Collaborate with product development, risk management, toxicology, usability, and regulatory partners to support aligned execution.
• Work with Technical Writers to ensure Instructions for Use (IFU) and labeling reflect validated cleaning and disinfection processes.
• Adhere to internal quality system requirements, including Quality System Procedures, Work Instructions, and applicable standards.

Benefits

• Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level