Biocompatibility Engineer – MR
Suzhou, China, China • Posted June 06, 2026
Job Type:
Full-time
Location:
Suzhou, China
Posted:
June 06, 2026
Category:
other-general
Application Deadline:
June 11, 2026
Role 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 lif...
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 lif...
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