Senior Engineer, Design Assurance QA R&D

About HOYA Surgical Optics (HSO)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, and Alive 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 self and are impact focused.Consider the needs, challenges, and objectives of every person they interact withExhibit positive reinforcement to help others succeed.Job DescriptionAbout the roleWorks closely with and have impact on: Global R&D team, Post market surveillance and Regulatory AffairsReports to: Senior Manager QA R&D HSOU, Global QA & ComplianceRole OverviewThe primary function of this position is to manage the Design Assurance activities for assigned projects in QA R&D Portfolio. This position collaborates with global cross functional team to achieve quarterly, midterm, and annual objectives and works under minimal supervision. The Senior Engineer, Design Assurance QA R&D is also responsible for ensuring that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, MDSAP requirements, Usability Engineering per IEC-62366-1 and Risk Management per ISO 14971.Duties and ResponsibilitiesPartner with R&D teams in the USA, Japan, and Singapore to ensure that design control is completed in accordance with procedures, Work Instructions (WI), regulatory requirements, and assure that required outputs have been completedManage all design assurance and usability engineering activities for R&D projects Ensure Design History Files (DHF) and all project design documentation are properly maintained in the Documentation Control System (i.e., Master Control).Ensure all design control deliverables, drawings are approved at the respective design gates Review design review materials to ensure consistency in the format and information reflected in the respective design gate Act as a core team lead for design control projects to review design verification protocols and reports, verify the requirement and criteria set are consistent in all design control deliverables, and advise on the approvers to be included for the documents.Assist in the development and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transferReview documents for labellingReview documents for biocompatibility studies per ISO 10993-1 biological evaluation of medical devicesReview and approve R&D documents (e.g., IQ , OQ, PQ, WI, etc.) within areas of responsibilityReview design transfer documents and coordinate transfer to both manufacturing and Regulatory Global Technical DossierProcess improvements initiatives within Design Assurance and Usability Engineering in line with regulations, standards and internal policies and proceduresMaintain and improve global operating procedures and work instructionsSupport lifecycle management of marketed productsConduct design assurance training to global R&D teams and other functions as neededSupport internal or external audits as needed with respect to R&D projects and related documentationCreate corrective action plans for findings from internal and external audits concerning design control procedures and deliverablesManage design change control for design control projects in accordance with SOPThoroughly review R&D technical reports to ensure quality and minimize deficienciesSupport and foster a performance drivenoriented cultureRequirementsExperienceAt least 10 years of experience in medical devicesAt least 6 years of working experience as Design Assurance andor Design QA or QA R&D Engineer in Medical Device Pharmaceutical product or optical engineering business field.Experience with New Product Development (NPD) projectsExperience in test method validation.Demonstrated knowledge of Design Assurance requirements per FDA Regulations, ISO 13485, EU MDR requirements, MDSAP requirements, Risk Management per ISO 14971, Usability Engineering per IEC-62366-1, Testing and Calibration per ISO 17025 and Biocompatibility studies per ISO 10993SkillsAccreditations Analytical mind capable of analyzing a broad spectrum of engineering and life science areasHaving a proven drive for results, is highly tenacious and persistent in the face of obstacles to ensure strategies are implemented over long term effectivelyDemonstrated experience working and leading in a matrix organization and in global teams (i.e., relationships with other departments, understanding of cross-functional priorities)Excellent written, verbal and presentation skills in English required as this is a global role.Strong intercultural experienceAbility to work collaboratively with scientist, engineers and other leadersStrong project management skillsStrong interpersonal, communication skills, and problem-solving skillsUnderstanding of the medical device business, preferred in ophthalmologyWorking knowledge of US, EU and JP standards for medical devices is desiredExcellent leadership skills & role model of HOYA Surgical Optics core values (i.e. Excellence, Passion, Innovative, Collaborative, Accountability)Ability to drive and execute responsibilities under minimal supervision Academic Qualifications BS degree in Engineering or Life Sciences with 10 years of relevant experience; MS preferredAuditor or Lead Auditor Certification for ISO 13485 andor MDSAP preferredASQ Certification (CQE or CQA) preferredSix Sigma Green Belt certification preferred Travel requirements Up to 20%USA domestic travel, and 1-2 international travel mainly Japan, Thailand or Singapore. By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.

Created: 2025-02-22