If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may c ontact 888-367-7223, option 5, for assistance.
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 biological evaluations need to be conducted to ensure devices meet and surpass ISO 10993, ISO 18562 and FDA Guidance documents. Coordinate testing with external labs, manage purchase orders, schedule testing conducted internally and externally.
You are responsible for:
Communicating with external test laboratories to manage test schedules and purchase orders.
Gather and prepare sample materials for shipment to external laboratories.
Generate biological test protocols to govern specific testing on materials under evaluation.
Working with product development teams 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.
Prioritizing project tasks to complete on schedule, maintaining quality of work and providing weekly project status reports.
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:
Bio Medical Master Degree(preferred) or relevant experience conducting biological assessments and testing of medical devices.
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 (preferred)
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 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’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. Learn more by watching this video.
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 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