Job Title
Biocompatibility Engineer – MR
Job Description
Job Description
As a Biocompatibility Engineer within the Business Unit MR, you will be accountable for the biological safety of patient‑contacting products across the full product lifecycle. You will provide in‑house 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 end‑to‑end 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 audit‑ready documentation and expert input.
- Provide global, cross‑site 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 QMS‑0002 and ISO 10993‑1.
- 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 re‑evaluations.
- Oversee chemical characterization and toxicological risk assessments (ISO 10993‑17/‑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 post‑market re‑evaluation.
- Provide expert support for regulatory submissions, audits, inspections, and CAPAs, ensuring documentation is complete, traceable, and audit‑ready.
You’re the Right Fit If
- Education: Master’s (PhD degree preferred) in Engineering or Science (e.g., biomedical, chemical, materials, toxicology); formal training in microbiology or toxicology preferred.
- Experience: 5–7+ 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 1, 5, 10, 12, 17, 18, 23), 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 non‑technical 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 well‑reasoned justifications and risk‑based rationales that withstand audit, inspection, and notified‑body scrutiny.
- Strong stakeholder‑management and influencing skills to align cross‑functional teams, challenge assumptions constructively, and drive decisions without direct authority.
- Ability to operate with confidence and composure in complex, high‑impact, 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 company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite 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 the lives of others.
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• Discover our rich and exciting history.
• Learn more about our purpose.
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 culture of impact with care here.