Philips Biological Safety Engineer in Monroeville, Pennsylvania
In this role, you have the opportunity to:
Produce clear/concise biological evaluations and test strategies for Respiratory Care medical devices.
You are responsible for:
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 result from CROs.
Learn from and adhere to 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 quality of work.
Work in a team environment; peer review work.
Work on multiple, concurrent project
You are a part of:
A dynamic Healthcare Technology organization that designs and develops life-saving Respiratory Care products. At Philips, we are passionate about improving quality of life with solutions designed around the needs of customers and their patients. Our tradition of innovation, combined with our ability to anticipate market needs, has made Philips a global leader in Respiratory Care.
To succeed in this role, you should have the following skills and experience:
Minimum of-PhD Degree in Material Science, Toxicology 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.
Basic understanding of global medical device regulations, requirements, and standards preferred.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
In return, we offer you:
The ability to collaborate with, learn and grow from colleagues in a highly complex, global organization where you can use your strengths to help drive strategic business initiatives for Philips. Additionally, we provide you a dynamic working environment in an innovative business, paired with a competitive salary, excellent benefits, and a supportive atmosphere where you can sharpen your talents with new challenges and career opportunities.
Why should you join Philips?
Working at Philips is more than a job. It is 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 is 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 regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.
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.
Equal Employment and Opportunity Employer/Disabled/Veteran