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 Electrical Engineer will focus on the technical execution of electrical 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 electrical 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 teams 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 electrical designs, driving the implementation of complex electrical systems from concept through to production. Focus on achieving performance, reliability, and regulatory compliance in every phase Oversee the design and development of electrical systems, including circuit design, PCB layout, power management, and signal processing for medical devices Ensure designs are optimized for safety, reliability, manufacturability, and compliance with medical device standards Manage the selection and integration of components, sensors, and electronic systems that meet design requirements and regulatory standards Perform detailed design reviews with internal teams and vendor partner, offering technical expertise to refine electrical architectures and ensuring they meet all Olympus R&D objectives Implement advanced electrical engineering techniques, such as circuit simulation, power analysis, thermal modeling, and PCB design optimization, to drive high performance and reliability Collaborate with cross-functional teams (mechanical, software, systems engineers) to ensure seamless integration of electrical designs into overall product architecture and meet system-level requirements Provide technical mentorship to junior engineers and vendor partner, 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 partner, focusing on detailed design compliance and technical specifications Develop and validate test protocols for electrical systems, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standards Drive innovation in electrical design, implementing new technologies to improve the functionality, performance, and reliability of medical devices Identify and implement process improvements for electrical engineering design, testing, and validation to optimize product development 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 electrical 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 partner 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 electrical design (e.g., Altium, MATLAB, SPICE), 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 electrical 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 electrical 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 electrical 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 partner 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 Biomedical / Electrical Engineering from a recognized university. Master’s in biomedical /electrical engineering will be an added advantage. Experience 10+ years of experience in electrical 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 electrical projects Strong technical background in electrical design, circuit board development, and compliance with regulatory standards Experience in medical device development is preferred Skills Strong technical expertise in electrical engineering, electronics, and mechatronics, with hands-on experience in R&D and/or sustaining engineering, especially in product development environments Proficient in circuit design, PCB layout, power management, analog and digital signal processing, and microcontroller-based systems Experience with electromagnetic compatibility (EMC) testing, electrical safety, and risk management practices Experience working with vendor partner 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 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 schematics, specifications, and compliance records for manufacturability and quality assurance Technical proficiency in PCB design tools (Altium/OrCAD), with the ability to review and provide feedback on schematics, component selection, and PCB manufacturing outputs Understanding of electromagnetic compatibility (EMC) challenges in electrical designs, contributing to design solutions to mitigate risks Knowledge of manufacturing processes for electrical components and an ability to assist in resolving complex technical issues with a practical approach Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in electrical R&D projects Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders Show more Show less
