Biocompatibility Engineer – MR

Job Title

Job Description

Job Description

As a Biocompatibility Engineer within the Business Unit MR you will be accountable for the biological safety of patientcontacting products across the full product lifecycle. You will provide inhouse expertise and leadership to ensure MR products meet global biocompatibility cleaning and microbiological requirements enabling regulatory compliance audit readiness and execution of the MR business roadmap.

Your Role

• Provide endtoend ownership for biocompatibility & reprocessing of MR products.
• Define and execute biological safety strategies aligned with ISO 10993 ISO 14971 FDA guidance and MDR requirements.
• Author review and approve Biological Evaluation Plans (BEPs) Biological Evaluation Reports (BERs) and related risk assessments.
• Coordinate and oversee biocompatibility & reprocessing and testing with external GLP laboratories.
• Embed biological safety considerations into design change control sterilization and lifecycle maintenance activities.
• Support regulatory submissions audits inspections and CAPA activities with auditready documentation and expert input.
• Provide global crosssite support to MR teams in Pune (India) Suzhou (China) and Best (The Netherlands).

Key Responsibilities

• Act as Biocompatibility SME for MR owning the execution of the Biological Safety Evaluation (BSE) process in accordance with MR QMS0002 and ISO 109931.
• Lead Initial Data Collection device/material categorization and risk analysis ensuring correct classification of patient contact contact duration and intended use.
• Author review and approve Biological Evaluation Plans (BEPs) defining biological endpoints test strategies justifications for omissions and alignment with FDA and MDR expectations.
• Perform and document Biological Safety Gap Analyses (BGAs) and Biological Risk Assessments (BRAs) to evaluate new products changes and reevaluations.
• Oversee chemical characterization and toxicological risk assessments (ISO/18 TTC) including evaluation of extractables and leachables.
• Coordinate and technically approve biocompatibility testing with external GLP laboratories and review test protocols and reports.
• Author review and approve Biological Evaluation Reports (BERs) integrating all data to conclude on biological safety and suitability for intended use.
• Ensure biological safety is embedded in design control change management sterilization reprocessing and lifecycle maintenance including postmarket reevaluation.
• Provide expert support for regulatory submissions audits inspections and CAPAs ensuring documentation is complete traceable and auditready.

Youre the Right Fit If

• Education: Masters (PhD degree preferred) in Engineering or Science (e.g. biomedical chemical materials toxicology); formal training in microbiology or toxicology preferred.
• Experience: 57 years of hands-on experience leading biocompatibility evaluations for medical devices including test strategy lab oversight and BEP/BER authorship.
• Standards & Regulations: Demonstrated working knowledge of ISO 10993 (Parts) ISO 14971 ISO/TS 21726 (TTC) FDA Biocompatibility Guidance (2023) EN 10993-1 and GB/T 16886.1 and applicable Guobiao standards.
• Regulatory Application: Proven ability to apply these standards within a risk-management framework to support audits inspections and global submissions (FDA MDR).

Soft Skills & Behavioral Expectations

• Strong written and verbal communication skills with the ability to clearly articulate complex scientific and technical concepts to both technical and nontechnical stakeholders.
• Proven capability to author clear concise and defensible records (e.g. BEPs BERs BRAs BGAs) suitable for inclusion in the Design History File (DHF) and for direct use in regulatory submissions (FDA MDR and other global authorities).
• Ability to apply sound scientific judgment and translate it into wellreasoned justifications and riskbased rationales that withstand audit inspection and notifiedbody scrutiny.
• Strong stakeholdermanagement and influencing skills to align crossfunctional teams challenge assumptions constructively and drive decisions without direct authority.
• Ability to operate with confidence and composure in complex highimpact and evolving environments balancing speed quality and compliance.

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 companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
About Philips
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If youre 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 culture of impact with care here.