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 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 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 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 #J-18808-Ljbffr
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