Senior R&D Engineer, Cleaning & Disinfection

Job Title

Job Description

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.

Your role:

• 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.

Youre the right fit if:

• Youve 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 Bachelors degree required Masters 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.
• Youre an are effective collaborator across engineering quality regulatory and external testing partners and have the ability to travel up to 10% of the time.

How we work together

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 companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in New Kensington PA is $102000 to $163200.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills experience business needs geographical location and internal equity.

In addition other compensation such as an annual incentive bonus sales commission or long-term incentives may be offered. 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. Details about our benefits can be found here.

At Philips it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position you must reside in or within commuting distance to New Kensington PA.

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This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.