Senior Biocompatibility Engineer

BioTalent; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BioTalent in Irvine, CA seeks a Senior Biocompatibility Engineer to lead biocompatibility programs for new product development and sustaining engineering, with deep ISO 10993 and ISO 11979 expertise. You will author and review biocompatibility documentation, evaluate external chemistry data, manage CROs, and collaborate with global teams and stakeholders across the product lifecycle.

Strong communication skills are essential to translate complex data into actionable decisions and ensure

Qualifications

• Biocompatibility expertise required.
• Experience with ISO 10993 and ISO 11979.
• Authoring and reviewing biocompatibility documentation.

Responsibilities

• Author and maintain biocompatibility documentation per ISO 10993/11979.
• Perform risk analysis and support biocompatibility assessments.
• Review external chemistry data and provide feedback.

Skills

Biocompatibility

ISO 10993

ISO 11979

Documentation

Cross-functional communication

CRO management

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