Job Description

JOB DESCRIPTION

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 a...

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