Digital Engineering Head

3 weeks ago

Hyderabad, Telangana, India Olympus Medical Systems India Pvt Ltd Full time
Key Responsibilities
  • Functional Setup: Oversee the setup and management of the digital engineering function, optimizing workflows, task assignments, hiring/team set-up, and resource management.
  • Ideation and Implementation: Develop and implement enhancements to digital engineering processes and tools, aiming to increase product development efficiency, communication, and quality.
  • Collaboration and Alignment: 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 priorities.
  • Technical Training and Knowledge-Sharing: Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus' digital standards.
  • Resource Planning and Talent Growth: 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 projects.
  • Continuous Improvement: Implement continuous improvement initiatives within the digital engineering function, driving technical process enhancements and increasing the efficiency and quality of digital product development across teams.

 

NPD and Stakeholder Management:
  • Delivery and Execution: 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 engineering.
  • Strategic Oversight: 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 objectives.
  • Digital Strategy: Define and execute the digital strategy for medical devices, focusing on software development, data analytics, cloud solutions, connectivity, and user experience.
  • Technical Oversight: Oversee the design and development of digital systems that enhance device functionality, data security, and remote monitoring capabilities.
  • Integration and Collaboration: Manage the integration of digital components with hardware, firmware, and communication systems to create cohesive and user-friendly medical products.

 

Project Management:
  • Strategic Interface: 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 strategy.
  • Technical Roadmaps: Develop and manage technical roadmaps with input from vendor partners, ensuring timelines, milestones, and resource planning are optimized for the digital engineering function.
  • Risk Management: Oversee coordination between vendor partners and hardware/software development teams, ensuring adherence to Olympus' digital system design control procedures and driving continuous improvements.
  • Validation and Testing: Provide high-level guidance on digital system validation and testing strategies.

 

Regulatory & Compliance:
  • Regulatory Compliance: Ensure that all digital product development activities meet regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications.
  • Point of Escalation: 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.
  • Documentation and Risk Management: Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations, identify potential technical risks, and implement mitigation strategies.
  • Problem-Solving: 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.
  • Experience: 14+ years of overall experience in digital engineering, cloud systems, AI/ML development, or related fields with 10+ years in medical devices domain.
  • Leadership Experience: 5+ years of experience with a medical devices or technology company in a leadership role.
  • Technical 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.
  • Project Management Skills: Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning.
  • Regulatory Knowledge: 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.
  • Award-winning Leader: Proven track record of leading teams in the design and development of digital systems and software solutions.

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