Senior Biomedical Engineer

Job Title: Senior Biomedical Engineer

Works closely with and have impact on: Global Quality, Global Regulatory, Operations

Reports to: Director of Biomedical Research

Function: Research & Development

Work Location/Site: Irvine, CA

Role Overvie

wThe Senior Biomedical Engineer is a subject matter expert for biocompatibility of ophthalmic medical devices, with a primary focus on intraocular lenses (IOLs). This role requires in-depth expertise in ISO 11979-5 and the ISO 10993 series, combined with a strong background in materials science, analytical chemistry, and chemistry-based testing. The individual will function as a contributor, providing scientific leadership to support product development, regulatory compliance, and biocompatibility related activities

.
Duties and Responsibiliti

• esServe as the biocompatibility subject matter expert for intraocular lenses (IOLs) and associated delivery system
• s.Develop and execute biological evaluation strategies in accordance with ISO 10993-1, ISO 11979-5, and related standard
• s.Design, review, and interpret analytical and chemistry-based testing data (e.g., GC-MS, HPLC, LC-UV) and translate results into regulatory-relevant conclusion
• s.Manage and technically oversee external CROs, including protocol review, study oversight, and report revie
• w.Perform biological evaluations, risk assessments, safety risk impact assessments (SRIAs), and gap assessments to identify testing needs, scientific rationales, and risk mitigation
• s.Collaborate cross-functionally with R&D, Regulatory Affairs, Quality, Manufacturing, and Supplier Quality team
• s.Write and review detailed technical reports to support global biocompatibility related matters ensuring scientific rigor, clarity, and compliance with regulatory standards and internal quality system

s.
Requireme

ntsExperie

• nceMinimum of 5–7 years of experience in biomedical research, medical device biocompatibility, or related fiel
• ds.Direct experience supporting biocompatibility assessments for implantable medical devices, preferably ophthalmic devic
• es.Hands-on experience with analytical and chemistry-based testing in support of biocompatibility (e.g., E&L, material characterizatio
• n).Experience authoring protocols, technical reports, and regulatory-facing documentati

on.
Skills/Accreditat

• ionsExpert-level proficiency in ISO 11979-5 and ISO 10993 series standa
• rds.Strong background in materials science, polymer chemistry, and analytical scien
• ces.Experience with analytical techniques such as GC-MS, HPLC, LC-UV, ICP-MS,
• etc.Excellent technical writing and report authoring ski
• lls.Strong risk assessment, critical thinking, and problem-solving abilit
• ies.Excellent communication and cross-functional collaboration ski

lls.
Academic Qualifica

• tionsMaster's degree or PhD in Materials Science, Biomedical Engineering, Chemistry, Analytical Sciences, or a closely related f
• ield.Advanced academic training with a strong emphasis on chemistry and analytical techniques is requ

ired.
Travel Requir

• emen