Hoya Surgical Optics
Sr/Scientist, Biomedical research
Hoya Surgical Optics, Irvine, California, United States, 92713
HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.HSO way of workingIn fulfilling our roles, we areAccountable for our own capabilities and development,Focused on delivering results without excuses, andAlive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.We are looking for people whoSee beyond themselves and are impact-focused,Consider the needs, challenges, and objectives of
every person
with whom they interact, andExhibit positive reinforcement to help others succeed.About the roleWorks closely with and have impact on:
R&D, Quality, Operations, Regulatory Affairs, Clinical AffairsReports to:
Director, Biomedical ResearchFunction:
Research and DevelopmentWork Location/Site : Irvine, California / USA OfficeRole OverviewThis position is responsible to ensure the biocompatibility of intraocular lenses, related ophthalmic devices, and to achieve business and operational objectives as determined by Director, Biomedical Research.In-depth knowledge of biocompatibility standards, including ISO 10993 series, specifically ISO 10993-18, ISO 11979-5, and ISO 11979-4, as well as MDR guidelines for EU submissions are key success factors for this position. The ideal candidate will have experience in the ophthalmic field, particularly with Class IIb devices (under MDR), and a strong understanding of global regulatory requirements, including FDA regulations and biocompatibility standards in China, Japan, and other Asian markets.Duties and ResponsibilitiesLead activities related to biocompatibility assessment to ensure compliance with ISO 10993 series, ISO 11979-5, and ISO 11979-4 standards for several pipelines and existing products, which encompass all project aspects ranging from technical documentation, risk and impact assessments of tests/standards, and validation assessment of changes and vendor management.Initiate and conduct shelf life studies to determine the stability and safety of medical devices over time.Manage change requests related to manufacturing processes, design modifications, packaging, sterilization, and other critical aspects of device production.Comply with MDR guidelines for EU submissions, which includes to prepare and review technical documentation.Write and review detailed technical reports related to biocompatibility, ensuring accuracy and compliance with regulatory standards and internal quality systems.Conduct gap assessments to identify discrepancies between current practices and updated standards, and develop mitigation strategies to ensure compliance.Stay up-to-date with FDA regulations and biocompatibility-related regulations in China, Japan, and other Asian markets to ensure all products meet global regulatory requirements.Work closely with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing for successful product development and compliance.Contribute, plan, and co-ordinate activities with internal and external stakeholders for (but not limited to) testing, preparing of samples, shipping, tracking etc.Other duties as assigned by the Head of Biomedical Engineering which may include assignments to support and work closely with other functions/departments within and across the organization.RequirementsExperienceAt least 5 years' experience of biomedical research in biomedical research, with a focus in ISO10993, ISO 11949-5, and 11979-4 standards and testing.Experience with Class 2B/3 medical devices, specifically intraocular lenses.Supported regulatory submissions, prepared and updated biocompatibility-related documents.Skills/AccreditationsExcellent technical writing skills with experience in preparing biocompatibility reports.Adept in ISO11979-5 and 10993 series of standards.Creative and to continue challenging status quo to find solutions.Keen Learner and to continuously learn to develop modern technology and innovation.Excellent verbal and written communication skills in technical and non-technical areas.Attention to details, able to work independently, multi-task and as a part of a multidisciplinary team.Academic QualificationsBachelor’s degree in science, engineering, or related fields.Master's degree or PhD is preferred.By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy.We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.
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every person
with whom they interact, andExhibit positive reinforcement to help others succeed.About the roleWorks closely with and have impact on:
R&D, Quality, Operations, Regulatory Affairs, Clinical AffairsReports to:
Director, Biomedical ResearchFunction:
Research and DevelopmentWork Location/Site : Irvine, California / USA OfficeRole OverviewThis position is responsible to ensure the biocompatibility of intraocular lenses, related ophthalmic devices, and to achieve business and operational objectives as determined by Director, Biomedical Research.In-depth knowledge of biocompatibility standards, including ISO 10993 series, specifically ISO 10993-18, ISO 11979-5, and ISO 11979-4, as well as MDR guidelines for EU submissions are key success factors for this position. The ideal candidate will have experience in the ophthalmic field, particularly with Class IIb devices (under MDR), and a strong understanding of global regulatory requirements, including FDA regulations and biocompatibility standards in China, Japan, and other Asian markets.Duties and ResponsibilitiesLead activities related to biocompatibility assessment to ensure compliance with ISO 10993 series, ISO 11979-5, and ISO 11979-4 standards for several pipelines and existing products, which encompass all project aspects ranging from technical documentation, risk and impact assessments of tests/standards, and validation assessment of changes and vendor management.Initiate and conduct shelf life studies to determine the stability and safety of medical devices over time.Manage change requests related to manufacturing processes, design modifications, packaging, sterilization, and other critical aspects of device production.Comply with MDR guidelines for EU submissions, which includes to prepare and review technical documentation.Write and review detailed technical reports related to biocompatibility, ensuring accuracy and compliance with regulatory standards and internal quality systems.Conduct gap assessments to identify discrepancies between current practices and updated standards, and develop mitigation strategies to ensure compliance.Stay up-to-date with FDA regulations and biocompatibility-related regulations in China, Japan, and other Asian markets to ensure all products meet global regulatory requirements.Work closely with cross-functional teams, including R&D, Quality, Regulatory Affairs, and Manufacturing for successful product development and compliance.Contribute, plan, and co-ordinate activities with internal and external stakeholders for (but not limited to) testing, preparing of samples, shipping, tracking etc.Other duties as assigned by the Head of Biomedical Engineering which may include assignments to support and work closely with other functions/departments within and across the organization.RequirementsExperienceAt least 5 years' experience of biomedical research in biomedical research, with a focus in ISO10993, ISO 11949-5, and 11979-4 standards and testing.Experience with Class 2B/3 medical devices, specifically intraocular lenses.Supported regulatory submissions, prepared and updated biocompatibility-related documents.Skills/AccreditationsExcellent technical writing skills with experience in preparing biocompatibility reports.Adept in ISO11979-5 and 10993 series of standards.Creative and to continue challenging status quo to find solutions.Keen Learner and to continuously learn to develop modern technology and innovation.Excellent verbal and written communication skills in technical and non-technical areas.Attention to details, able to work independently, multi-task and as a part of a multidisciplinary team.Academic QualificationsBachelor’s degree in science, engineering, or related fields.Master's degree or PhD is preferred.By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy.We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.
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