Head System

Purpose of the Role:

The Head System will act as the head of system engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to product development (e.g., Systems Design, Systems Integration, Verification, Validation, Design & Development Planning, Requirements Engineering, etc.). The individual will function as a steward of our product development processes, ensuring alignment with Olympus' global system engineering strategy.

The ideal candidate shall be a hands-on technical leader with extensive experience in developing medical systems. This role will involve setting up the system engineering R&D function for India scope and managing system engineering projects, ensuring seamless collaboration with Olympus’ global R&D and India leaders. The incumbent will be responsible for technical oversight, driving project delivery, and ensuring that projects meet the company’s product development standards with minimal operational input from Olympus HQ.

This role will also ensure high-quality engineering outcomes in the development of medical systems by leading the systems engineering team through the design, verification, and validation processes. By overseeing the systems engineering function, this individual will ensure compliance with regulatory standards such as FDA Design Controls and ISO requirements. The position requires strong leadership, technical proficiency, and the ability to align system R&D activities with Olympus’ offshore vision.

Key Responsibilities:

Functional Setup:

1. Lead the functional setup and management of the system engineering function, optimizing workflows, task assignment, hiring/team set-up, and resource management
2. Seek to ideate enhancements to systems engineering processes and tools with the goal of increasing product development efficiency, communication, and/or quality
3. Collaborate with global PMO teams to ensure the engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities
4. Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ technical standards
5. Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future systems engineering projects
6. Implement continuous improvement initiatives within the system engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams
7. Identify and implement cutting-edge technologies and systems engineering practices to improve product performance and drive innovation
8. Participate in strategic planning and provide technical insights to support long-term growth and competitiveness
9. Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance
10. Create systems to ensure all updates/changes are communicated across sites/employees

NPD and Stakeholder Management:

1. Head the system engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of system engineering
2. Provide strategic oversight and guidance for system R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives
3. Drive the development and maintenance of system architecture, including hardware, software, and firmware integration
4. Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations
5. Act as the subject matter expert on system design control, providing guidance to product development teams (both internal and external)
6. Ensure system designs are optimized for performance, manufacturability, safety, and reliability
7. Stay current with emerging technologies and advancements relevant to medical device systems engineering
8. Ensure that system design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders
9. 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 system designs
10. Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays
11. Champion continuous improvement initiatives for systems engineering processes, tools, and methodologies
12. Drive innovation in medical device design and engineering practices to enhance product quality and reduce time to market

Project Management:

1. Head the Systems 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
2. Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the systems engineering function
3. Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed
4. Manage and oversee the maintenance of technical RAID logs, working with vendor partners to ensure risks are identified, escalated, and addressed promptly
5. Oversee coordination between vendor partners and software development teams to ensure seamless integration of system designs into broader product architectures
6. Ensure adherence to Olympus’ design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability
7. Lead design reviews, technical assessments, and decision-making processes to ensure project milestones are met
8. Collaborate with external partners, suppliers, and contractors as needed
9. Provide high-level guidance on the verification and validation testing strategies proposed, ensuring they meet Olympus’ quality and performance specifications

Regulatory & Compliance:

1. Ensure that all product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications
2. 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
3. Manage systems requirements, traceability, and change management to ensure clear documentation and compliance with design controls
4. Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations

Risk Management & Problem-Solving:

1. Identify potential technical risks and implement mitigation strategies
2. Provide technical guidance in solving engineering challenges during the product development lifecycle

Person Specification:

Education

A degree or higher qualification in Systems Engineering, Biomedical Engineering, or related fields from a recognized university.

Master's in systems engineering will be an added advantage.

Experience

• 14+ years of overall experience in systems 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 system development, system integration, and product design
• 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 systems

Skills

• Strong technical background in systems engineering, system integration, and model-based 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 Model-Based Systems Engineering (MBSE) and requirements management tools, ensuring cross-functional collaboration to achieve business objectives
• Capable of developing deliverables to document system designs for high-volume manufacturing and quality compliance
• Experience planning and mitigating system-level risks using tools like FMEA and fault tree analysis
• Strong knowledge of system integration methodologies for medical devices and the ability to solve complex technical problems with sound judgment
• Proficiency in working with requirements management systems, 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