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 Senior Manager will act as the head of mechanical engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to product development, and function as a steward of our mechanical development processes. The ideal candidate will be a hands-on technical leader with extensive experience in developing mechanical components and systems for medical devices. This individual will be responsible for setting up the mechanical engineering R&D function for the global scope of work and owning the execution of engineering projects, ensuring alignment with Olympus’ global R&D strategy. The role is responsible for driving the R&D operations for India, focusing on leading mechanical engineering teams and project delivery in collaboration with the global R&D and India leaders. The incumbent will spearhead project planning, budget management, and technical oversight, ensuring seamless coordination across teams to meet project timelines and deliverables with minimal operational input from Olympus HQ. On the technical front, this role will provide strategic oversight while ensuring high-quality engineering outcomes in the development of medical devices. By leading mechanical engineering initiatives, this individual will guide the design, analysis, prototyping, verification, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls and ISO requirements. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns mechanical R&D performance with Olympus’ offshore vision. Key Responsibilities: Functional Setup: Lead the functional setup and management of the mechanical engineering function, optimizing workflows, task assignments, hiring/team set-up, and resource management Identify and implement cutting-edge technologies and mechanical engineering practices, such as advanced simulation (FEA/CFD), material optimization, and additive manufacturing to improve product performance and drive innovation Hands on experience in designing and developing mechanical components in systems for manufacturing Seek to ideate enhancements to mechanical engineering processes, CAD tools, and methodologies, aiming to increase product development efficiency, communication, and quality Collaborate with global Project managers teams to ensure the engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ technical standards Implement continuous improvement initiatives within the mechanical engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future mechanical engineering projects Participate in strategic planning and provide technical insights to support long-term growth and competitiveness Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance Create systems to ensure all updates/changes are communicated across sites/employees NPD and Stakeholder Management: Head the mechanical engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of mechanical engineering Provide strategic oversight and guidance for mechanical R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations Act as the subject matter expert on mechanical design controls, providing guidance to product development teams (both internal and external) Ensure that mechanical design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders Drive the development of IP strategies by working with PMO and legal teams, ensuring vendor partners adhere to Olympus’ requirements for protecting intellectual property in product designs Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays Project Management: Head the Mechanical Engineering R&D function to serve as the strategic interface between global PMO and vendor partners, providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the mechanical engineering function Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed Manage and oversee the maintenance of technical RAID logs, working with vendor partners to ensure risks are identified, escalated, and addressed promptly Oversee coordination between vendor partners and software development teams to ensure seamless integration of mechanical designs into broader product architectures Ensure adherence to Olympus’ design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability Provide high-level guidance on prototyping, verification, and validation testing strategies, ensuring they meet Olympus’ quality and performance specifications Regulatory & Compliance: Ensure that all product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications Act as the point of escalation for technical and regulatory compliance matters, ensuring external and internal teams engage with safety certification bodies and comply with applicable standards Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations Risk Management & Problem-Solving: Identify potential technical risks and implement mitigation strategies Provide technical guidance in solving engineering challenges during the product development lifecycle Person Specification: Education A degree or higher qualification in Mechanical Engineering, Biomedical Engineering, or related fields from a recognized university. A master's in mechanical engineering will be an added advantage. Experience 14+ years of overall experience in mechanical engineering or medical device development with 10+ years in medical devices domain 5+ years of experience with a medical devices company in a leadership role 9+ years of experience in mechanical design, prototyping, materials selection, and product development Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.) Proven track record of leading teams in the design and development of Class II/III medical devices Skills Strong technical background in mechanical engineering, with experience in Medical Device development and/or sustaining engineering efforts Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning Proven ability to work through medical device product lifecycle management, including FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring alignment with strategic roadmaps Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth Familiarity with CAD tools and simulation tools, ensuring cross-functional collaboration to achieve business objectives Capable of developing deliverables to document mechanical designs for high-volume manufacturing and quality compliance Proficiency in working with PLM (Product Lifecycle Management) systems and conducting risk analyses and DFMEAs Excellent stakeholder management skills across PMO leads and vendor partners, ensuring timely project delivery and alignment with strategic goals Experience managing large data sets, financial analysis, and P&L ownership, utilizing these insights to drive process improvements and operational efficiencies Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, and leadership Strong project management skills, with the ability to manage multiple projects simultaneously Excellent communication, leadership, and problem-solving skills Show more Show less
