Global Biocompatibility Lead - NPD & Sustaining

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

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