Job
Description
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. Since its inception, Olympus has remained committed to its founding principles of integrity, innovation, and quality. Over the years, the company has diversified its portfolio, excelling in various fields including endoscopy, microscopy, life sciences, and digital imaging. Purpose of the Role: The Staff Embedded Software Engineer will focus on the technical execution of embedded software development 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 PMO to drive the design, development, and troubleshooting of embedded software 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 embedded software, 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 embedded software architectures and ensuring they meet all Olympus R&D objectives Oversee the design, development, and deployment of embedded software and firmware for medical devices Ensure the integration of embedded systems with hardware components, sensors, user interfaces, and communication protocols Lead the development of real-time, safety-critical systems with a focus on reliability, efficiency, and performance Implement advanced embedded software engineering techniques and embedded systems validation. Collaborate with cross-functional teams (mechanical, hardware, and systems engineers) to ensure seamless integration of embedded software 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 embedded software, 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 software 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 development tools and workflows, including implementing software for embedded systems, debugging tools, 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 embedded software developed in the function meets high standards for performance, durability, and compliance Direct hands-on debugging and software validation, focusing on early-stage system validation, software integration, and design tuning to meet evolving project needs Drive continuous improvement initiatives to optimize technical workflows, reduce development cycles, and improve overall engineering output quality by integrating feedback from testing and real-world results Ensure all software 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 embedded software 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 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 Person Specification: Education A degree or higher qualification in Computer Science Engineering from a recognized university. Master's in computer Science Engineering will be an added advantage. Experience 10+ years of experience in embedded software development, with a mix of technical and managerial responsibilities Proven experience in collaborating with PMOs and global teams on embedded software engineering projects Strong technical background in embedded software and firmware development Experience in medical device development is preferred Skills Strong technical expertise in embedded systems engineering, including hands-on experience in R&D and/or sustaining engineering, especially in product development environments 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 Strong experience in developing embedded software and firmware for medical devices, including real-time operating systems (RTOS) and safety-critical systems Proficient in programming languages such as C, C++, and assembly, with expertise in low-level hardware interaction and device drivers Strong understanding of microcontroller, microprocessor, and digital signal processing (DSP) architectures Experience with wireless communication protocols (e.g., Bluetooth, Wi-Fi) and cybersecurity in medical devices Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC62304), 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 Ability to develop and contribute to design documentation, including source code documentation, technical specifications, and compliance records for manufacturability and quality assurance Knowledge of real-time systems, software development and device drivers, contributing to design solutions to mitigate risks Understanding of software lifecycle management, software verification, and validation for embedded systems, including experience with managing design for reliability and scalability Experience with requirements management systems contributing to risk analysis and DFMEA processes in embedded software 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 Show more Show less
