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Job Information

Philips Biological Safety Engineer in Monroeville, Pennsylvania

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In this role, you have the opportunity to

Join Philips as a Biological Safety Engineer. The selected candidate will work under direct supervision of the Engineering Lead to produce clear and concise biological evaluations and test strategies for medical devices.Focus will be assessing and testing materials for compliance to ISO 10993 and ISO 18562.

You are responsible for

  • Working with a team to assess products for compliance to international biological standards

  • Documenting biological test strategies and managing tests with outside labs

  • Documenting biological risk assessments and analyzing result from CROs

  • Learning from and adhering to internal quality manual (Quality System Procedures, Work Instructions, Forms)

  • Maintaining and updating current biocompatibility Quality System Procedures, Work Instructions, and Forms

  • Developing and conducting biocompatibility training programs

  • Providing weekly project status reports

  • Prioritizing project tasks to complete on schedule while maintaining high quality of work

  • Working in a team environment; peer review work

  • Working on multiple, concurrent project

You are a part of

Products and Systems team within Philips Respironics.

To succeed in this role, you should have the following skills and experience

  • PhD Degree in Material Science, Toxicology or equivalent bioengineering field with emphasis on biomaterials, polymers and organic chemistry

  • 3+ years professional experience (post-doc, industry, lab, etc.)

  • Lab management experience preferred

  • Knowledge of biological test methods for compliance to ISO 10993 and ISO 18562

  • 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

  • Basic understanding of global medical device regulations, requirements, and standards preferred

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 .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

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