About the Company
Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering innovative solutions that enhance people's lives every day. With a rich history spanning nearly a century, Olympus has continuously pushed the boundaries of what's possible in the realms of medical, scientific, and imaging technology. This is an incredibly exciting time to join Olympus as we embark on a strategic journey to establish a core R&D; presence in India, a hub for cutting-edge development. Our mission is to push the frontiers of technology and innovation, shaping impactful solutions in the fields of endoscopy, microscopy, life sciences, and digital imaging. This opportunity offers highly motivated professionals the chance to work on pioneering projects, driving breakthroughs that will shape the future of technology and healthcare. Join us, grow in tech and digital fields, and be part of a transformative team dedicated to delivering world-class outcomes. Purpose of the Role: The Staff Systems Engineer will focus on the technical execution of systems engineering projects within Olympus. Reporting to the Associate Director, this role emphasizes technical leadership while maintaining some project management responsibilities. The individual will collaborate closely with Global R&D; and India leads to drive the design, development, and troubleshooting of systems for medical devices. This position will take charge of strategic technical oversight, particularly in vendor partner management, ensuring high-quality engineering outcomes and adherence to regulatory standards such as FDA Design Controls. While contributing to project planning and delivery, the focus will be on leading technical initiatives, ensuring alignment with the broader R&D; strategy and offshore operational 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 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 phase.
• Perform detailed design reviews with internal teams and vendor partners, offering technical expertise to refine systems architectures and ensuring they meet all Olympus R&D; objectives
• Oversee the full systems engineering lifecycle: requirements definition, system architecture, risk management, design, verification, validation, and release.
• Drive the development and maintenance of system architecture, including hardware, software, and firmware integration.
• Manage systems requirements, traceability, and change management to ensure clear documentation and compliance with design controls.
• Implement advanced systems engineering techniques, such as requirements management, system modeling, simulation, and validation to drive high performance and reliability.
• Collaborate with cross-functional teams (mechanical, software, hardware engineers) to ensure seamless integration of designs into overall product architecture and meet system-level requirements.
• Provide 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 strategies.
• Ensure seamless communication of technical updates between stakeholders, including Olympus global teams, regulatory bodies, and vendor partners, focusing on detailed compliance and technical specifications.
• Develop and validate test protocols for systems, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standards. Project Management:
• Lead technical tracking of project progress,



developing detailed Gantt charts and project plans that map out technical milestones, dependencies, and resource needs for systems R&D; activities.
• Coordinate with the PMO teams to ensure technical objectives are aligned with project timelines, adjusting designs and technical approaches to mitigate risks or delays.
• Create and manage technical resource plans, ensuring that internal engineering teams and vendor partners have the tools, talent, and resources required to meet demanding project timelines.
• Proactively troubleshoot and resolve technical challenges, leveraging advanced engineering methodologies like root cause analysis (RCA), failure mode effect analysis (FMEA), and reliability testing to resolve bottlenecks.
• Support RAID management by identifying and documenting key technical risks, ensuring that each risk has an associated mitigation plan grounded in strong engineering fundamentals.
• Provide in-depth technical reports to the PMO on project progress, focusing on design validation, testing outcomes, technical issues encountered, and proposed engineering solutions.
• Oversee technical escalations, ensuring that all technical roadblocks are swiftly identified and addressed, with proposed solutions backed by solid technical rationale. Practice Development:
• Lead technical setup of engineering tools and workflows, including implementing software for systems design, lab setups, and testing protocols for streamlined development within the function.
• Develop and oversee technical processes, including change control, design reviews, and prototype testing, ensuring the function operates with cutting-edge engineering efficiency
• Establish advanced testing and validation protocols, ensuring that all systems developed in the function meet high standards for performance, durability, and compliance.
• Direct hands-on prototyping and debugging, focusing on early-stage system validation, component selection, and design tuning to meet evolving project needs.
• Drive continuous improvement initiatives to optimize technical workflows, reduce design cycles, and improve overall engineering output quality by integrating feedback from testing and real-world results.
• Ensure all systems designs meet global regulatory and safety standards, working closely with regulatory bodies and certification teams to ensure the function’s output aligns with industry regulations.
• Manage technical knowledge-sharing sessions within the function, facilitating the exchange of engineering know-how between internal teams and external vendor partners to elevate the overall technical skill set. Regulatory & Compliance:
• Support the Associate Director in ensuring product development aligns with regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications.
• Assist in engaging with external teams and certification bodies to ensure compliance with applicable safety standards.
• Implement 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 regulations. Risk Management & Problem-Solving:
• Work with the team to identify technical risks and support the development of mitigation strategies.
• Provide input and technical support to address engineering challenges throughout the product development process. Why work at Olympus? At Olympus,



we are committed to fostering a high-performing culture, a team-oriented environment, and empowering everyone to shine. Our shared values—integrity, empathy, long-term view, agility, and unity—form the foundation of our culture and guide our behavior. These values ensure that our people feel they are making a meaningful difference every single day. What we are looking for:

Education:
• A degree or higher qualification in Biomedical / System Engineering from a recognized university.
• Masters in biomedical /System engineering will be an added advantage.

Experience:
• 10+ years of experience in System Engineering R&D; in the medical devices domain, with a mix of technical and managerial responsibilities.
• Proven experience in collaborating with PMOs and global teams on system projects.
• Strong technical background in system design, circuit board development, and compliance with regulatory standards.
• Experience in medical device development is preferred. Skills
• Strong 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 environments
• Expertise in systems engineering methodologies, including requirements management, risk analysis, and system integration
• Experience working with vendor partners on R&D; projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirements
• Familiarity 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 regulations
• Experience 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 growth
• Experience with model-based systems engineering (MBSE) tools and methodologies
• Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives
• Ability to develop and contribute to design documentation, including requirements specifications, risk management files, and compliance records for manufacturability and quality assurance
• Knowledge of systems integration and architecture, contributing to design solutions to mitigate risks
• Understanding of software lifecycle management (e.g., EN62304) and experience with managing system-level risks and verification
• Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in system R&D; projects
• Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery
• Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency
• Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders. Apply Now: To submit your interest in this opportunity, select "Apply for this job." Want to know more? Confidential discussions are welcome; contact our TA Partner. Olympus is an Equal Opportunity Employer. "We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a nondiscriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply."

📌 Staff System Engineer (Hyderabad)
🏢 Olympus
📍 Hyderabad