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 Senior Reliability Engineer will be responsible for the design, development of protocols and conduct reliability testing of Olympus medical devices. This role demands in-depth technical expertise in Reliability engineering, experience in ensuring the reliability of safety-critical systems and its components to meet regulatory guidelines. The Senior Reliability Engineer will work collaboratively with cross-functional teams and external partner laboratories to deliver high-quality, high-availability and high-reliability products that meet performance, safety, and compliance standards. 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 planning, design and development of reliability requirements, and execute testing of electro-mechanical medical systems.
• Design and optimize reliability GSOPs for reliability related tests including shelf-life testing, operational lifetime testing and aging related testing
• Shall be experienced with RTA, Accelerated Aging Tests, ALT, HALT/HASS, Fatigue and Durability Testing and Shelf-Life Validation testing.
• Conduct Failure Modes and Effects Analysis (FMEA/DFMEA/UFMEA).
• Perform root cause analysis of field failures and customer complaints. Support CAPA teams with data analysis.
• Analyze reliability data and generate reliability growth models.
• Perform risk management analysis, DFMEA/FMEA
• Can lead CAPA activities through all stages from initiation to VoE and closure.
• Support risk management activities in accordance with ISO 14971.
• Work with design, systems, software, manufacturing, quality,



and regulatory teams to improve product reliability.
• Evaluate component reliability and supplier reliability performance.
• Develop reliability metrics such as MTBF, MTTF, Failure Rate, Availability, and Reliability Demonstration Test results.
• Support regulatory submissions and compliance activities.
• Drive continuous improvement initiatives using reliability and field performance data. Develop and validate test protocols for medical device systems, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standards Project Management:
• Support RAID management by identifying and documenting key technical risks
• Support in creating in-depth technical reports to the PMO on project progress, focusing on design validation, testing outcomes, technical issues encountered, and proposed engineering solutions
• Work with external vendor labs to ensure on-time delivery of Test Reports with > 95% FTR Regulatory & Compliance:
• Support the organization in ensuring reliability of products so that it 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
• Help maintain documentation in accordance with Good Manufacturing Practices (GMP) and quality system regulations Continuous Improvement:
• Drive innovation in reliability engineering, implementing new technologies to improve the functionality, performance, and reliability of medical devices
• Stay current with advancements in reliability engineering technologies, industry trends, and medical device innovations 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 Electrical/Mechanical/Biomedical Engineering from a recognized university.
• Masters in Reliability engineering or business will be an added advantage.
• ASQ Certified Reliability Engineer (CRE) certification is a string plus.

Experience:
• 6-10 years of experience in electrical/mechanical/biomedical engineering R&D; with at least 5+ years in reliability engineering in the medical devices domain.
• Proven experience in collaborating with PMOs and global teams on electrical projects.




• Strong technical background in medical device design and reliability testing.
• Experience in SW Reliability and Cybersecurity is an added advantage. Skills
• Strong technical expertise in reliability engineering, especially in product development environments.
• Strong expertise in planning, designing protocol and testing for reliability of products and components, particularly RTA, Accelerated aging testing, ALT, HALT/HASS
• Proficient in Reliability Modeling & Prediction of electro-mechanical devices (Medical devices highly preferred
• Experienced in generating reports on reliability metrics such as MTBF, MTTF, Failure Rate, Availability, and Reliability Demonstration Test results.
• Experience in statistical data analysis of field data using techniques like Weibull analysis and Wei-Bayes analysis.
• Experience in Risk Management, FMEA/DFMEA analysis, RCA, Hazard Analysis is a must.
• Experience in leading CAPA activities through all stages from initiation to VoE and closure.
• Experience in relevant regulatory compliance is a must.
• Experience in SW Reliability and SW Quality metrics is an added plus.
• 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.
• Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives.
• Knowledge of manufacturing processes for electrical components and an ability to assist in resolving complex technical issues with a practical approach.
• 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."

📌 Senior Reliability Engineer (Hyderabad)
🏢 Olympus
📍 Hyderabad