Senior Biological Safety Engineer

Philips•Murrysville, PA

1d•Onsite

About The Position

Working collaboratively with cross-functional teams to assess products for compliance with international biological and biocompatibility standards, developing and documenting biological test strategies and coordinating execution with external test labs and CRO partners. Documenting biological risk assessments, analyzing and interpreting test results received from CROs, and ensuring all findings are accurately captured in accordance with regulatory and quality expectations. Learning from, adhering to, and maintaining compliance with internal quality manuals, including Quality System Procedures, Work Instructions, and Forms; maintaining and updating current biocompatibility-related QSPs, WIs, and Forms to ensure ongoing alignment with regulatory and internal requirements. Developing and conducting biocompatibility training programs, work within a team environment to peer-review deliverables, and provide clear, consistent weekly project status updates to stakeholders. Managing and prioritizing multiple concurrent projects, balancing timelines and workload to ensure on-schedule completion while maintaining a high standard of quality and attention to detail.

Requirements

3+ years of experience in biocompatibility, including conducting biological assessments of medical devices and documenting biological test evidence to support FDA submittals.
Ability to work with outside test labs to generate test plans and evaluate results for compliance with biological standards.
Familiarity with applicable standards and regulations such as ISO 10993 and ISO 18562 (as applicable), FDA reprocessing guidance, and EU MDR (preferred).
Bachelor’s or Master’s degree in Engineering (Bioengineering or Biomedical Engineering – highly preferred) or similar discipline.
Excellent communicator, both written and verbal.
Strong practices in documentation.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Lab management experience is preferred.

Responsibilities

Assess products for compliance with international biological and biocompatibility standards.
Develop and document biological test strategies.
Coordinate execution of biological tests with external test labs and CRO partners.
Document biological risk assessments.
Analyze and interpret test results received from CROs.
Ensure all findings are accurately captured in accordance with regulatory and quality expectations.
Maintain compliance with internal quality manuals, including Quality System Procedures, Work Instructions, and Forms.
Maintain and update current biocompatibility-related QSPs, WIs, and Forms.
Develop and conduct biocompatibility training programs.
Peer-review deliverables within a team environment.
Provide clear, consistent weekly project status updates to stakeholders.
Manage and prioritize multiple concurrent projects.
Balance timelines and workload to ensure on-schedule completion while maintaining a high standard of quality and attention to detail.