Philips Biological Safety Engineer – Chemistry & Chemical Engineering
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
Job Title: Biological Safety Engineer
Job Id: 460475
- Bachelors or Master’s Degree in Material Science, Toxicology, or Chemical Engineering with emphasis on biomaterials, polymers and organic chemistry.
- Minimum of 5+ year’s professional experience
- Lab management experience preferred
- Knowledge of biological test methods for compliance to ISO 10993 and ISO 18562 (desired).
- Familiarity with FDA 2016 Guidance Document “Use of International Standard ISO 10993-1.”
- Experience conducting biological assessments of medical devices.
- Experience documenting biological test evidence to support FDA submittals.
- Experience working with outside test labs to generate test plans and evaluate results for compliance to biological standards.
- Understanding of global medical device regulations, requirements, and standards.
In this role, you have the opportunity to be part of Philips Sleep and Respiratory Care as a Biological Safety Engineer focused on Ventilation & related accessory products. You will be responsible for implementing technical strategies, evaluating, and developing products, and providing a superior level of technical support that benefits the organization. The position collaborates closely with Mechanical Engineers, Clinical Affairs, Marketing, Quality & Regulatory in the Ventilation business to develop and commercialize Class 2 medical devices. This position shall provide strategic direction related to the development of systems and programs for the following areas: Microbiology, Cleaning and Biocompatibility testing.
You are responsible for
- Formulates and executes on biocompatibility and cleaning test plans, protocols, and reports.
- Establish effective work processes and standardized procedures that ensure compliant documentation of routine testing results and timely completion of business milestones using industry-accepted scientific principles with independent test laboratories.
- Manage and maintain vendors including supporting audits of the contract facility.
- Author and review validations and product adoptions into existing cycles.
- Perform testing and maintains documentation to support the use facility of single-use and reusable products supporting ventilation.
- Encourage continuous process improvements environment.
- Additional responsibilities may be assigned, as required, by management.
- Work with a team to assess products for compliance to international biological standards.
- Document biological test strategies and manage testing with outside test labs.
- Document biological risk assessments and analyze results from CROs.
- Learn from and adhere to the internal quality manual (Quality System Procedures, Work Instructions, Forms).
- Maintain and update current biocompatibility Quality System Procedures, Work Instructions, and Forms.
- Develop and conduct biocompatibility training programs.
- Provide weekly project status reports.
- Prioritize project tasks to complete on schedule while maintaining the quality of work.
- Work in a team environment; peer review work.
- Work on multiple, concurrent project
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