Exciting opportunity to play an important role in improving and saving lives around the world through generating Biological Risk Assessments and Testing strategies for Philips Sleep & Respiratory Care products, ensuring they are safe for use by the patient population.Your role:
Responsible for preparation and documentation of Biological Risk Assessments, Testing Strategies and Dossiers for Sleep & Respiratory Care medical devices. Will also manage testing with outside test labs and analyze result from CROs.
Learn from and adhere to internal quality manual (QMS procedures, Work Instructions, and Forms)
Maintain and update current biocompatibility QMS Procedures, Work Instructions, and Forms.
Develop and conduct biocompatibility training programs.
Provide weekly project status reports.
Assist development teams in selecting proper materials for use in medical devices.
Reporting to the Manager-Biological Safety Engineering, you will work cross-functionally and collaborate with R&D, NPD, CRO’s, Regulatory Agencies internal/external scientists and other stake holders.
This role may require travel up to 10%.
You're the right fit if:
You’ve acquired a minimum of 3 years’ experience in Biological Risk Assessments, with proven experience in Biological Test methods/strategies for compliance to ISO 10993 (required) and ISO 18562 (desired).
Your skills include conducting/documenting Biological Risk Assessments, documenting test evidence to support regulatory agency submittals, as well as interaction with Regulatory Agencies to address test strategies and questions related to Biological Rick assessments.
You have a minimum of a Bachelor’s degree in Material Science, Toxicology, Chemical Engineering, with an emphasis on biomaterials, polymers and organic chemistry (Required) Master’s Degree desired. Knowledge of FDA 2020 Guidance Document “Use of International Standard ISO 10993-1” (Required)
You have a strong understanding of global medical device regulations/requirements/standards and experience working with outside test labs to generate test plans/evaluate results for compliance with biological standards.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
About Philips:We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
Learn more about our business (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency Details:The pay range for this position is $92,000 to $158,000, annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.#LI-PH1It 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
