About this opportunity
BioTalent lists this Senior Biocompatibility Engineer opportunity in irvine, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
We're seeking a Senior Biocompatibility Engineer with strong biocompatibility expertise to support our new product development (NPD) and sustaining engineering activities. This role requires deep knowledge of ISO 10993 and ISO 11979, hands‑on experience authoring biocompatibility documentation, and the ability to work cross‑functionally with global teams. Strong communication skills matter as much as technical depth here — you'll be reviewing external chemistry data, working directly with CROs, and collaborating closely with internal stakeholders throughout the product lifecycle.
Responsibilities
Author and maintain biocompatibility documentation in accordance with ISO 10993 and ISO 11979
Perform risk analysis and produce supporting documentation for biocompatibility assessments
Review external chemistry characterization data and provide technical feedback
Design biocompatibility studies and review study protocols
Work directly with CROs (Contract Research Organizations) on study execution and oversight
Provide end‑to‑end support across new product development (NPD) and sustaining engineering activities
Collaborate cross‑functionally with internal stakeholders and global teams throughout the product lifecycle
Requirements
Strong biocompatibility background with expertise in ISO 10993 and ISO 11979
5–7 years of relevant experience (open to junior or more senior candidates — overall strength of background matters more than exact years)
Deep chemistry knowledge
Strong cross‑functional communication skills, with experience working across global teams
Ophthalmic‑specific industry experience is a strong plus, though not required
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Worksite address
irvine, CA, 92713, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.