- 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've acquired a minimum of 3 years' experience in Biological Risk Assessments, with proven experience in Biological Test methods/strategies for compliance to ISO required) and ISO 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 " (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.
- 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.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
- Read more about our employee benefits.
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Senior Biological Safety Engineer - Pittsburgh, United States - Philips
Description
Job Title
Senior Biological Safety EngineerJob Description
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:
You're the right fit if:
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.
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.
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-PH1
This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.
Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.
Senior Biological Safety Engineer professionals in Pittsburgh
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S.A. Malec
Using knowledge for causal feature selection