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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 Overview The 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 Responsibilities
Serve as the biocompatibility subject matter expert for intraocular lenses (IOLs) and associated delivery systems.
Develop and execute biological evaluation strategies in accordance with ISO 10993-1, ISO 11979-5, and related standards.
Design, review, and interpret analytical and chemistry-based testing data (e.g., GC-MS, HPLC, LC-UV) and translate results into regulatory-relevant conclusions.
Manage and technically oversee external CROs, including protocol review, study oversight, and report review.
Perform biological evaluations, risk assessments, safety risk impact assessments (SRIAs), and gap assessments to identify testing needs, scientific rationales, and risk mitigations.
Collaborate cross-functionally with R&D, Regulatory Affairs, Quality, Manufacturing, and Supplier Quality teams.
Write and review detailed technical reports to support global biocompatibility related matters ensuring scientific rigor, clarity, and compliance with regulatory standards and internal quality systems.
Requirements Experience
Minimum of 5–7 years of experience in biomedical research, medical device biocompatibility, or related fields.
Direct experience supporting biocompatibility assessments for implantable medical devices, preferably ophthalmic devices.
Hands-on experience with analytical and chemistry-based testing in support of biocompatibility (e.g., E&L, material characterization).
Experience authoring protocols, technical reports, and regulatory-facing documentation.
Skills/Accreditations
Expert-level proficiency in ISO 11979-5 and ISO 10993 series standards.
Strong background in materials science, polymer chemistry, and analytical sciences.
Experience with analytical techniques such as GC-MS, HPLC, LC-UV, ICP-MS, etc.
Excellent technical writing and report authoring skills.
Strong risk assessment, critical thinking, and problem-solving abilities.
Excellent communication and cross-functional collaboration skills.
Academic Qualifications
Master's degree or PhD in Materials Science, Biomedical Engineering, Chemistry, Analytical Sciences, or a closely related field.
Advanced academic training with a strong emphasis on chemistry and analytical techniques is required.
