Senior Biological Safety Engineer

Job Title

Senior Biological Safety Engineer

Job Description

Your role:

• 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.

You're the right fit if:

• You’ve acquired 3+ years of experience in biocompatibility, including conducting biological assessments of medical devices and documenting biological test evidence to support FDA submittals.
• Your skills include:
  • 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).
  • Lab management experience is preferred.
• You have a bachelor’s or master’s degree in Engineering (Bioengineering or Biomedical Engineering – highly preferred) or similar discipline.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent communicator, both written and verbal, and have strong practices in documentation.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

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.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details

The pay range for this position in PA is $102,000 to $163,000.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

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.

  

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to Murrysville, PA.

#ConnectedCare

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 including Disability/Vets and maintains a drug-free workplace.