Sr. Biomedical Engineer

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.

Travel Requirements: None