Head of Digital

Purpose of the Role:

The Head of Digital will act as the head of digital engineering R&D and the business process owner for Olympus’s Standard Operating Procedures related to digital product development (e.g., Digital Systems Design, Cloud Architecture, Data Engineering, AI/ML Development, Software Integration, etc.), and function as a steward of our digital engineering processes.

The ideal candidate will be a hands-on technical leader with extensive experience in digital systems development for medical devices or related industries. This individual will be responsible for setting up the digital engineering R&D function for the global scope of work and owning the execution of digital engineering projects, ensuring alignment with Olympus’ global R&D strategy. 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 digital systems and software. By leading digital engineering initiatives, this individual will guide the design, development, integration, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls, ISO, and IEC standards. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns digital R&D performance with Olympus’ offshore vision.

Key Responsibilities:

Functional Setup:

1. Lead the functional setup and management of the digital engineering function, optimizing workflows, task assignments, hiring/team set-up, and resource management2. Ideate and implement enhancements to digital engineering processes and tools, aiming to increase product development efficiency, communication, and quality3. Collaborate with global PMO teams to ensure the digital engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities4. Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ digital standards5. Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future digital engineering projects6. Implement continuous improvement initiatives within the digital engineering function, driving technical process enhancements and increasing the efficiency and quality of digital product development across teams7. Identify and implement cutting-edge technologies and digital engineering practices, such as cloud computing, data engineering, artificial intelligence (AI), and machine learning (ML) to improve product performance and drive innovation8. Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance9. Create systems to ensure all updates/changes are communicated across sites/employees

NPD and Stakeholder Management:

1. Head the digital engineering function to own and account for the delivery, execution, and management of all NPD activities within the India scope of digital engineering2. Provide strategic oversight and guidance for digital R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives3. Define and execute the digital strategy for medical devices, focusing on software development, data analytics, cloud solutions, connectivity, and user experience4. Oversee the design and development of digital systems that enhance device functionality, data security, and remote monitoring capabilities5. Manage the integration of digital components with hardware, firmware, and communication systems to create cohesive and user-friendly medical products6. Collaborate with Olympus PMO teams to develop and monitor technical roadmaps7. Act as the subject matter expert on digital system design controls, providing guidance to product development teams (both internal and external)8. Ensure that digital engineering solutions meet performance, cost, scalability, and security requirements through effective review and communication with global stakeholders9. 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 digital solutions10. Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays11. Drive innovation by identifying and implementing emerging technologies such as artificial intelligence (AI), machine learning (ML), and advanced data analytics into medical device systems12. Promote continuous improvement of digital engineering processes, tools, and methodologies, including DevOps practices, cloud solutions, and software development lifecycles13. Stay current with trends in digital health, data science, and medical technology to ensure the organization remains competitive in the industry

Project Management:

1. Head the Digital 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 strategy2. Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the digital engineering function3. Manage and oversee the maintenance of technical RAID logs, working with vendor partners to ensure risks are identified, escalated, and addressed promptly4. Oversee coordination between vendor partners and hardware/software development teams5. Ensure adherence to Olympus’ digital system design control procedures and drive continuous improvements6. Provide high-level guidance on digital system validation and testing strategies

Regulatory & Compliance:

1. Ensure that all digital product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications2. 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 standards3. 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 strategies2. Provide technical guidance in solving digital engineering challenges during the product development lifecycle

Person Specification:

Education

A degree or higher qualification in Computer Science, Digital Systems Engineering, Software Engineering from a recognized institute.

A master’s in digital systems or software engineering will be an added advantage.

Experience

- 14+ years of overall experience in digital engineering, cloud systems, AI/ML development, or related fields with 10+ years in medical devices domain- 5+ years of experience with a medical devices or technology company in a leadership role- 9+ years of experience in software development, data engineering, cloud computing, and AI/ML- 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 digital systems and software solutions

Skills

- Strong technical background in digital engineering, cloud architecture, software integration, and AI/ML with experience in Medical Device development and/or sustaining digital 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 digital system lifecycle management, including FDA Design Controls and international standards (e.g., ISO14971, IEC60601), ensuring alignment with strategic roadmaps- Familiarity with AI/ML technologies and their application in medical devices for diagnostics, data analysis, or predictive modeling- Experience with digital platforms for remote patient monitoring, telemedicine, or mobile health (mHealth)- Proficiency in using modern software development tools and methodologies, such as Agile, DevOps, and CI/CD pipelines- Knowledge of user-centered design and the development of intuitive user interfaces (UI) for medical devices- Experience with cybersecurity risk management for connected and networked medical devices- Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth- Familiarity with cloud platforms (AWS, Azure, Google Cloud) and AI/ML development tools (TensorFlow, PyTorch) ensuring cross-functional collaboration to achieve business objectives- Capable of developing deliverables to document digital system designs for scalability, security, and compliance- Experience planning and mitigating cybersecurity risks using tools like threat modeling and penetration testing- Strong knowledge of data engineering, data processing pipelines, and cloud-based data storage for medical device software- Proficiency in working with agile development processes, conducting risk analyses, and software FMEAs- 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

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