Job title
Senior biological safety engineer
Job description
In this role, you have the opportunity to make life better:
Rewarding opportunity to play a critical role in the development of life-saving respiratory care products by producing clear/concise biological evaluations and test strategies.
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:
Philips’ sleep & respiratory care is dynamic healthcare technology organization that designs and develops life-saving respiratory care productsAt philips, we are passionate about improving quality of life with solutions designed around the needs of customers and their patientsOur 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’ll need a customer-first attitude and the following:
Targeting a minimum of phd in material science, toxicology, chemical engineering with emphasis on biomaterials, polymers and organic chemistry (may consider strong master’s degree level candidates)
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.
Understanding of global medical device regulations, requirements, and standards.
Us work authorization is a precondition of employmentThe company will not consider candidates who require sponsorship for a work-authorized visa.
#li-ph1
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 philipsAdditionally, 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 jobIt’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutionsHelp us improve the health and well-being of billions of people, every yearUltimately creating a career that no one could have planned forEven you.
Visit our careers website to explore what it’s like working at philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.
Effective tuesday, january 4, 2022, all u.s.-based employees are required to be fully vaccinated against covid as a condition of employment at philipsEmployees with a sincerely held religious belief and/or disability impacting their ability to obtain the covid vaccine can request a reasonable accommodation.
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 requestYou may contact 888-367-7223, option 5, for assistance.
Philips electronics ltd is committed to treating all people in a way that allows them to maintain their dignity and independenceWe welcome and encourage applications from people with disabilitiesAccommodations are available on request for candidates taking part in all aspects of the selection process.
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 workforceIn 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 opportunity employer/disabled/veteran
Hiring insights
Job activity
Posted 30+ days ago
