About the Company:

Olympus Corporation is a globally renowned leader in endoscopy enabled healthcare, pioneering creative 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 Systems Engineer will contribute to the design, development, and integration of complex medical devices, working across various engineering disciplines such as mechanical, electrical, software, and embedded systems.

The Systems

Engineer will be responsible for ensuring the seamless integration of subsystems, managing system-level requirements, and supporting verification and validation activities. The role requires a solid understanding of medical device development processes, regulatory standards, and the ability to work collaboratively within a cross-functional team environment.

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:

- Support the design and development of system architectures for medical devices, ensuring that all subsystems (mechanical, electrical, software, and embedded systems) are well-integrated.
- Define system requirements and specifications based on user needs, regulatory requirements, and design inputs.
- Create and maintain system models and documentation (e.g., block diagrams, interface definitions, and design specifications) to guide product development.
- Support the full systems engineering lifecycle: requirements definition, system architecture, risk management, design, verification, validation, and release.
- Manage systems requirements, traceability,



and change management to ensure clear documentation and compliance with design controls.
- Support in the implementation of 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.
- Support the development and execution of system-level verification and validation (V&V;) plans to ensure the product meets performance, safety, and regulatory requirements.
- Assist in test planning, execution, and analysis, including functional testing, performance testing, and risk management evaluations.

Continuous Improvement:

- Stay updated on industry trends and best practices in systems engineering and medical device development.
- Contribute to continuous improvement initiatives by suggesting new tools, methods, and processes for better systems integration and design efficiency.

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
- Assis tin the implementation of 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.

Why work at Olympus?

At Olympus, we are committed to fostering a high-performing culture, a collaborative 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:

- 4-6 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
- 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 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."

📌 System Engineer (Hyderabad)
🏢 Olympus
📍 Hyderabad