Bio Compatibility Safety Engineer
- Murrysville, PA
Bio Compatibility Safety Engineer
In this role, you have the opportunity to
Work closely with the mechanical development engineers and design quality engineers to assess medical devices and determine what evaluations need to be made, to ensure devices meet and surpass ISO and FDA standards.
You are responsible for
- Working with a team to assess products for compliance to international biological standards, as well as doing peer review work.
- Documenting biological test strategies and managing testing with outside test labs.
- Documenting biological risk assessments and analyzing result from Contract Resource Organizations (CRO's).
- Learning from and adhering to internal quality manual (Quality System Procedures, Work Instructions, Forms, etc.).
- Maintaining and updating current bio-compatibility Quality System Procedures, Work Instructions and Forms.
- Developing and conducting bio-compatibility-training programs.
- Prioritizing project tasks to complete on schedule, maintaining quality of work and providing weekly project status reports.
You are a part of
Describe in two to three lines the place of the role in the organization and the team culture.
To succeed in this role, you should have the following skills and experience
- PhD Degree (required), strong preference given to candidates with focus in Material Science, Toxicology or Polymer Science with an emphasis on biomaterials, polymers and organic chemistry
- 3+ years of experience performing material assessments and testing
- Knowledge of biological test methods for compliance to ISO 10993 (required) and ISO 18562 (a plus)
- Experience conducting biological assessments and 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
- Basic understanding of global medical device regulations, requirements, and standards preferred
- Familiarity with FDA 2016 Guidance Document "Use of International Standard ISO 10993-1" (a plus)
In return, we offer you
The opportunity to join a growing organization where you will have the chance to use all parts of your education in order to make improvements and develop the processes for multiple Philips locations.
Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
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