R&D Engineer, Cleaning & Disinfection

Philips • New Kensington, PA

6d • 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.
Your role:
​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.

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.

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: Mid Level