Senior R&D Engineer, Cleaning & Disinfection

Philips • New Kensington, PA

6d • $102,000 - $163,200 • Onsite

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

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