R&D Test Engineer (Cleaning & Disinfection)
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1 Vacancy
Job Summary
Job Title
R&D Test Engineer (Cleaning & Disinfection)Job Description
Your role:
- Supporting the development evaluation and validation of cleaning and disinfection processes for reusable medical devices ensuring all requirements are clear risk-based and testable. Executing hands-on and simulated use testing both independently and in collaboration with internal teams and external laboratories.
- Authoring reviewing and maintaining test protocols reports and validation documentation in compliance with FDA ISO and global regulatory standards. Working closely with Technical Writers to ensure Instructions for Use (IFU) and labeling accurately reflect validated processes.
- Evaluating material compatibility and durability impacts from repeated cleaning and disinfection and assist with accelerated aging and use-life studies to assess long-term device performance. Participating in technical and design reviews to ensure cleaning and disinfection strategies are robust and aligned with product requirements.
- Investigating cleaning or disinfection-related issues contribute to root cause analysis and support corrective and preventive action (CAPA) activities. Collaborating with product development risk management toxicology usability and regulatory partners to drive aligned execution and continuous improvement.
- Managing assigned project tasks providing regular status updates to stakeholders and adhere to internal quality system requirements including procedures work instructions and applicable standards. Ensuring all activities support the delivery of safe effective and compliant medical devices.
Youre the right fit if:
- Youve acquired 2 years of experience in cleaning and disinfection reprocessing sterilization sciences materials compatibility (or similar) within medical device development (preferred) or no prior experience required with a co-op or internship related to the above.
- Your skills include:
- Experience executing or supporting cleaning and/or disinfection validation testing (preferred).
- Working knowledge of root cause analysis and participation in failure investigations and CAPA activities (preferred)
- Familiarity with applicable standards and regulations such as ISO 17664 ISO 10993 (as applicable) FDA reprocessing guidance and EU MDR (preferred).
- You have abachelors degree in Engineering (highly preferred) or a comparable discipline such as Bioengineering Materials Science Chemistry or similar.
- 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 excellent communicator both written and verbal and have strong practices in documentation.
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 PA is $72000 to $114000.
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.
#ConnectedCare
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.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
