The VP of R&D is a senior leadership role responsible for overseeing and coordinating the development of innovative medical device products on an international scale. The position involves managing research and development team members (including software quality assurance); defining, supporting, and improving the product development process; working with the Product Management team and company leaders to define and execute the company’s product development strategy; and supporting strategic partnership activities.
Your responsibility
  • Technical Leadership: Possess exemplary technical leadership skills, including the ability to define and oversee system architecture design, ensuring scalability, reliability, and performance of software and hardware solutions. Select and implement development methodologies and tools best suited for the company’s needs
  • Technology Innovation: Stay abreast of emerging technologies, trends, and best practices in software development, algorithm design, and medical imaging, and drive innovation within the organization.
  • Strategic Planning: Develop and implement strategic plans for R&D activities in alignment with the company's overall objectives, focusing on software development, algorithm design, and medical imaging technologies.
  • Team Leadership: Lead and manage a multidisciplinary team of software engineers, algorithm developers, imaging specialists, hardware engineers, and software quality assurance personnel, fostering a culture of innovation, collaboration, and continuous improvement.
  • Project Management: Oversee the planning, execution, and delivery of R&D projects, ensuring adherence to timelines, budgets, and quality standards.
  • Software Quality Assurance: Champion software quality assurance practices and establish robust testing frameworks and processes to ensure the delivery of high-quality, reliable software products.
  • Regulatory Compliance: Ensure that all R&D activities comply with relevant quality and global regulatory requirements, such as CE and US FDA for medical devices, and support efforts to obtain the necessary global approvals and certifications for new products and technologies.
  • Collaboration: Collaborate closely with cross-functional teams, including product management, quality assurance, regulatory affairs, and clinical affairs, to drive product development initiatives from concept to commercialization.
  • Risk Management: Identify and mitigate technical, regulatory, and business risks associated with R&D projects.
  • Resource Allocation: Manage resource allocation across R&D projects, balancing competing priorities and ensuring efficient use of personnel, budget, and equipment.
  • Personnel Development: Conduct regular performance evaluations of team members, providing feedback, coaching, and mentorship to support their professional growth and development.
  • Intellectual Property Management: Manage the intellectual property portfolio related to software, algorithms, and imaging technologies, including patent filings and enforcement activities.
  • Vendor and Partner Management: Evaluate and manage relationships with external vendors, contractors, and research partners, ensuring alignment with R&D goals and objectives, quality of work product, and timeliness of delivery.
  • Continuous Improvement: Implement processes and methodologies to drive continuous improvement in R&D operations, including optimization of workflows, adoption of new tools and technologies, and implementation of best practices.
  • Communication: Effectively communicate R&D plans, progress, and results to senior management, stakeholders, and external parties, including investors, customers, and regulatory agencies.
  • Budgeting and Financial Management: Develop and manage R&D budgets. Track expenses and resource utilization to ensure financial objectives are met while maintaining quality and compliance.
  • Ethical Conduct: Ensure that all R&D activities are conducted with the highest standards of ethical conduct, integrity, and professionalism, with a focus on patient safety and product efficacy.
Qualifications
  • Technical Expertise: Deep technical expertise in areas relevant to medical device R&D, such as software development, algorithm design, medical imaging, regulatory compliance, and quality assurance, with a strong understanding of the unique challenges and requirements of the industry.
  • Leadership Skills: Proven leadership and management skills, including the ability to inspire and motivate cross-functional teams, drive innovation, foster a culture of collaboration and continuous improvement, and effectively navigate organizational dynamics to achieve strategic objectives.
  • Team Building and Development: Proven ability to attract, develop, and retain top talent, fostering a culture of learning, growth, and accountability within the R&D organization, and providing mentorship and support to team members to help them reach their full potential.
  • Strategic Vision: Strong strategic thinking and vision, with the ability to develop and implement R&D strategies aligned with broader business goals and market trends, identifying opportunities for growth and differentiation in the competitive landscape.
  • Regulatory Knowledge: In-depth knowledge of quality and regulatory requirements and standards governing medical devices, including CE and FDA regulations (e.g., 21 CFR Part 820) and international standards (e.g., ISO 13485), and experience navigating the regulatory approval process for new products.
  • Communication Skills: Excellent communication and interpersonal skills, with the ability to effectively communicate complex technical concepts to diverse audiences, including senior management, stakeholders, regulatory agencies, and external partners.
  • Project Management: Strong project management skills, including the ability to prioritize competing demands, manage resources effectively, and drive projects to successful completion within budget and timeline constraints.
  • Problem-Solving Abilities: Exceptional problem-solving abilities and analytical skills, with a proactive and pragmatic approach to identifying and addressing technical, regulatory, and business challenges throughout the product development lifecycle.
  • Ethical Standards: Commitment to upholding the highest standards of ethical conduct and integrity in all aspects of R&D activities, with a focus on patient safety, product efficacy, and compliance with regulatory requirements and industry best practices.
  • Global Perspective: Strong global awareness and cultural sensitivity to effectively interact with people in different countries and regions with varying customer needs and regulatory landscapes.
  • International Commercialization: Experience developing products for and commercializing products in major international markets, such as the US, EU, APAC, South America, etc.