Job Title

Purpose of the Role:The Senior Systems Engineer for Medical Devices is responsible for the holistic design, integration, and validation of complex medical device systems. This role requires a broad understanding of engineering disciplines, regulatory requirements, and the ability to coordinate and balance multiple technical and non-technical factors. The Senior Systems Engineer works closely with cross-functional teams to ensure that the system-level design aligns with both user needs and regulatory standards, while also meeting safety, performance, and quality requirements.This position will take ownership of project delivery both internal and external, ensuring high-quality engineering outcomes and adherence to regulatory standards such as FDA Design Controls. While contributing to project planning, the focus will be on executing technical initiatives and ensuring alignment with the overall project goals. The role requires proactive liaison with internal teams and external partners to maintain seamless coordination and ensure the timely achievement of project milestones.Key Responsibilities:NPD and Stakeholder Management:Lead the design and development of system architectures for medical devices, ensuring that all subsystems (mechanical, electrical, software, and embedded systems) are well-integratedDefine system requirements and specifications based on user needs, regulatory requirements, and design inputsCreate and maintain system models and documentation (e.g., block diagrams, interface definitions, and design specifications) to guide product developmentLead hands-on development and execution of systems designs, driving the implementation of complex systems from concept through to production, with a focus on achieving performance, reliability, and regulatory compliance in every phasePerform detailed design reviews with internal teams and vendor partners, offering technical expertise to refine systems architectures and ensuring they meet all Olympus R&D objectivesOversee the full systems engineering lifecycle: requirements definition, system architecture, risk management, design, verification, validation, and releaseDrive the development and maintenance of system architecture, including hardware, software, and firmware integrationManage systems requirements, traceability, and change management to ensure clear documentation and compliance with design controlsImplement advanced systems engineering techniques, such as requirements management, system modeling, simulation, and validation to drive high performance and reliabilityCollaborate with cross-functional teams (mechanical, software, hardware engineers) to ensure seamless integration of designs into overall product architecture and meet system-level requirementsProvide technical mentorship to junior engineers and vendor partners, ensuring that best practices are followed and that technical decisions are aligned with Olympus’ long-term innovation strategiesDevelop and validate test protocols for systems, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standardsProject Management:Support RAID management by identifying and documenting key technical risksSupport in creating technical reports to the PMO on project progress, focusing on design validation, testing outcomes, technical issues encountered, and proposed engineering solutionsRegulatory & Compliance:Support the Associate Director in ensuring product development aligns with regulatory and industry standards, including FDA, CE, ISO, and other relevant certificationsAssist in engaging with external teams and certification bodies to ensure compliance with applicable safety standardsImplement rigorous risk management processes, including hazard analysis, fault tree analysis (FTA), and failure modes and effects analysis (FMEA)Help maintain documentation in accordance with Good Manufacturing Practices (GMP) and quality system regulationsContinuous Improvement:Stay updated on industry trends, emerging technologies, and advancements in system engineering to drive innovation Identify opportunities for improvement in existing product designs, focusing on performance optimization, cost reduction, and ease of useMentor junior engineers, providing guidance on best practices in mechanical design and medical device developmentPerson Specification:EducationA degree or higher qualification in Biomedical / System Engineering from a recognized university.Masters in biomedical /System engineering will be an added advantage.Experience6-10 years of experience in System Engineering R&D in the medical devices domain, with a mix of technical and managerial responsibilitiesProven experience in collaborating with PMOs and global teams on system projectsStrong technical background in system design, circuit board development, and compliance with regulatory standardsExperience in medical device development is preferredSkillsStrong technical expertise in systems engineering, systems modeling, and requirements management, with hands-on experience in R&D and/or sustaining engineering, especially in product development environmentsExpertise in systems engineering methodologies, including requirements management, risk analysis, and system integrationExperience working with vendor partners on R&D projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirementsFamiliarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulationsExperience in supporting project and program management efforts, with a focus on managing day-to-day vendor partner interactions, driving continuous improvement in engineering processes, and contributing to team growthExperience with model-based systems engineering (MBSE) tools and methodologiesComfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectivesAbility to develop and contribute to design documentation, including requirements specifications, risk management files, and compliance records for manufacturability and quality assuranceKnowledge of systems integration and architecture, contributing to design solutions to mitigate risksUnderstanding of software lifecycle management (e.g., EN62304) and experience with managing system-level risks and verificationExperience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in system R&D projectsEffective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project deliveryExperience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiencyStrong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders