R&D Director, China

Our ability to grow, develop new capabilities and serve even more patients around the world depends on associates like you, who are passionate about our mission. Thank you for considering this new opportunity to further unlock your potential.

JOB TITLE: R&D Director, China

Job Band: 4

Report to: Sr. Director, Systems Engineering, Global

JOB SUMMARY

We are seeking an accomplished leader who bears the responsibility of expanding R&D operations and fostering a culture of operational excellence. This strategic leadership position, leading a multi-disciplinary team, will architect and implement frameworks for operational excellence in the implementation of China specific programs, China product localization, and addressing regional design related quality issues so as to support China business growth and continuity.

The position requires a deep understanding of the Chinese healthcare market, broad product development knowledge and comprehensive management skills. The leader is required to provide direction and leadership to R&D team, foster a culture of excellence closely, collaborate effectively with cross functions such as quality, regulatory affairs, operations, and commercial in Local and Global. The leader will also serve as a key member of the Product Engineering Leadership Team as well as the China Transformation Program.

ESSENTIAL DUTIES

• R&D Strategy and Product Realization:

• Work independently in developing, planning and executing strategic plans for R&D initiatives in China, aligning with global R&D roadmap, overall business goals and market opportunities to ensure effective achievement of business goals and objectives
• Participates in company’s short and long-term planning and strategy, establishes priority and technical objectives.
• Manages and provides leadership for the function’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Design and implement comprehensive frameworks for R&D operational excellence, including standardized methodologies for project execution, resource optimization, and performance measurement
• Establish and oversee systematic approaches for local configuration management in the context of a global platform, resource allocation, and program execution locally while partnering closely with multiple global sites.
• Lead the development and execution of local strategic R&D programs and act as a key stakeholder on broader global programs.
• Monitor, analyze and identify emerging technologies, industry trends, competitor activities, and regulatory pathways to inform strategic R&D plan and decision-making
• Oversee the adaptation and customization of global products for the Chinese market, ensuring compliance with local standards and regulations.
• Lead the entire product development lifecycle from concept through commercialization, ensuring projects are delivered on time, within budget, and to the highest quality standards.
• Drive innovation and create a robust pipeline of new products and product enhancements tailored to the needs of the China market.
• Lead the localization projects for medical devices (instrument) and their disposal accessories to meet Chinese regulatory requirements and market needs.
• Ensure all design control processes are rigorously followed, and documentation meets both Terumo BCT's internal quality standards and Chinese regulatory requirements (NMPA, ISO 13485, etc.).
• Champion robust design for manufacturability (DFM), design for assembly (DFA), and design for reliability.
• Manage the R&D budget, resources, and capital equipment planning effectively.
• Be responsible for the development of solutions to problems of highly unusual complexity and broad company implications.
• Utilize technical, managerial expertise and creativity to evaluate proposed solutions, adaptations, and modifications to projects and products
• Act as primary interface with Authorities and be able to interpret, answer and state all product design and product technology relevant affairs during inspection or auditing.
• Develop and maintain strong relationships with CDMO partners to ensure high-quality production and timely delivery of products.

• Stakeholder Management & Cross-Function Collaboration:

• Serve as the key R&D interface for China leadership, providing strategic updates, aligning with business direction.
• Collaborate closely with global R&D teams to leverage core technologies and ensure alignment with global platforms.
• Communicate effectively with global R&D leadership to ensure alignment and integration of local initiatives with global strategies, to leverage core technologies and ensure alignment with global platforms.
• Collaborate with cross-functional teams, including regulatory affairs, quality assurance, marketing, and sales, to ensure successful product development and commercialization.
• Create and execute communication strategies that ensure effective execution across functional organizations and across multiple global locations.
• Utilize excellent communication and influencing skills to drive project success and foster strong internal and external relationships.
• Monitor and assess cultural indicators, adjusting approaches as needed to ensure successful adoption of new ways of working.

• Team Management & Development:

• Lead, coach, and develop a high-performing multi-disciplinary R&D team. Provide mentorship and professional development opportunities to team members, promoting a growth-oriented environment.
• Foster a culture of collaboration, innovation, accountability, and continuous improvement.

• Identify talent gaps and lead recruitment efforts to build a world-class R&D team in China.

MINIMUM QUALIFICATION REQUIREMENTS

Education

• A minimum of a bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related field. Masters or Advanced degree is desirable.

Experience

• A minimum of 15 years’ experience in medical device industry, with at least 5 years in a leadership role managing R&D organization and complex program execution.
• Proven track record of successfully leading the end-to-end development and commercialization of Class II/III medical devices (NMPA or equivalent).
• Strong knowledge of the Chinese healthcare market, including regulatory requirements and industry trends. Deep expertise in China NMPA regulatory submission processes and strong knowledge of ISO 13485, FDA QSR, and other relevant medical device standards.
• Strong understanding of Design Control, Change Control, Design Verification and Validation procedure.
• Solid experience in program management with proven track record.

Skills

• Willingness to take ownership and accept responsibility for actions and decisions.
• Be courageous in the face of tough situations and able to provide direct and actionable feedback.
• Excellent ability in finding problems. Able to look through the surface and diagnose the root cause.
• Strong analytical and problem-solving skills. Able to solve practical problems and interpret and communicate complex situations in a manner that allows maximum project implementation without compromising policy compliance.
• Master good conflict management skills, maturity and good judgment and be capable of communicating with a diverse range of individuals.
• Strong interpersonal savvy. Be able to build rapport and constructive relationships with different people internally and externally.
• Exceptional strategic thinking and business acumen, with the ability to translate business needs into a technical R&D strategy. Able to apply broad industry knowledge and commercial awareness to drive financial and operational performance across the businesses.
• Deal comfortably with ambiguity, uncertainty and unknown. Can handle risks effectively, decide and act without the total picture. Be calm, positive and productive even when things are up in the air.
• Ability to prioritize project activity, work effectively in a multi-functional team environment, and motivate others to reach objectives.
• Strong managerial and leadership skills. Able to coach, guide and motive team members to improve their performance, develop capability and drive for a common goal.
• Strong technical savvy and learning agility of state-of-the-art technology related to our products.

• Excellent understanding of quality management, risk management in product design & development.
• Excellent communication and presentation skills in both English and Mandarin, with the ability to influence stakeholders at all levels.

• Self-motivated, able to stay calm and poised in stressful, difficult, or ambiguous situations.

• Resiliency, rigor, and preciseness.

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

Travel Frequency:

About 15% domestica and international

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2024, Terumo Blood and Cell Technologies reached $1.5 billion in revenue.
• We employ nearly 8,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect – Appreciative of others
  • Integrity – Guided by our mission
  • Care – Empathetic to patients
  • Quality – Committed to excellence
  • Creativity – Striving for innovation

Terumo Blood and Cell Technologies is an Equal Opportunities Employer and welcomes applications from all sections of the community regardless of their gender, marital or family status, religious belief or political opinion, disability, race or ethnic origin, nationality, sexual orientation or age.