Save Job Back to Search Job Description Summary Similar Jobs Head R&D for a global CGM/BGM company Enjoy a competitive compensation package and a culture that values innovation About Our Client Our client is an innovator in the global Continuous Glucose Monitoring (CGM) and Blood Glucose Monitoring (BGM) industry, dedicated to developing cutting-edge, user-centric medical devices that empower diabetes patients to manage their health more effectively. With a strong commitment to technological breakthroughs and global market expansion, the company has established a solid reputation for adhering to strict international medical device standards and driving innovation in glucose detection technology. Backed by robust R&D investment and a collaborative corporate culture, it aims to redefine the future of diabetes care through transformative products. Job Description R&D Strategic Planning and Technology Roadmap Development Develop 3-5 year technology R&D roadmaps for BGM/CGM products aligned with the company's overall strategy, defining key breakthrough directions (e.g., high-sensitivity electrochemical/optical sensors, anti-interference test strip materials, miniaturized/intelligent detection instruments, user-friendly sampling systems). Monitor global BGM/CGM industry trends and technological advancements to provide data-driven decision support for the company's technology layout and market expansion. Plan platform capability development (e.g., universal detection modules, standardized test strip production processes) to support multi-scenario product expansion (home-use, clinical-use, pediatric-specific) and enhance technology reusability and R&D efficiency. End-to-End R&D Management and Product Commercialization Lead the full lifecycle management of BGM/CGM products from initiation to mass production, including requirements analysis (clinical, user, market), solution design, prototype development, clinical validation, regulatory submission, and production ramp-up-ensuring on-time, high-quality, and on-budget delivery. Address core technical challenges (e.g., enzyme activity stability, electrode response consistency, signal acquisition accuracy, anti-interference capability) by coordinating cross-disciplinary resources (chemical/biological materials, electronic engineering, software algorithms, clinical medicine) to meet or exceed industry performance standards. Lead regulatory compliance management, ensuring R&D adherence to NMPA (Class III), FDA 510(k), and CE MDR requirements. Oversee clinical evaluation, risk management (ISO 14971), and technical documentation (TD, DMR, DHF) preparation to accelerate time-to-market. Technical Team Building and Talent Development Design the R&D team's organizational structure and talent pipeline, building a high-performance unit capable of driving continuous innovation. Establish a technical talent cultivation system (internal training, external academic exchanges, project mentoring) to enhance team expertise in electrochemical detection, microfluidic design, low-power instrument development, and clinical data analysis. Foster an innovation culture, lead patent strategy (e.g., novel enzyme immobilization, anti-interference materials, intelligent calibration algorithms), and promote the transformation of technical achievements into product iterations. Cross-Functional Collaboration and Resource Integration Collaborate closely with the Product Department to review market requirements, ensuring R&D directions align with customer needs (hospitals, home users) and optimize product definition. Liaise with the Production Department to lead R&D-to-manufacturing technology transfer, resolving production technical issues to ensure quality stability and cost control during scaling. Technical Risk Control and Knowledge Management Identify R&D technical risks (e.g., enzyme activity decay, signal drift, clinical data deviations), develop mitigation plans (material screening, process optimization, expanded clinical samples), and track closure to ensure project risk controllability. Promote standardization of technical documentation (design records, test reports, process specs, BOMs) and establish a corporate BGM/CGM technical knowledge base to facilitate experience accumulation and cross-project knowledge sharing. The Successful Applicant Master's degree or higher in Chemistry, Biomedical Engineering, Materials Science, or a related field. Over 15 years of R&D experience in electrochemical platform detection products, with at least 8 years specifically in BGM/CGM (fingerstick or continuous glucose detection) product development. Proven team management experience: led an R&D team of 8+ members through the complete lifecycle of at least one BGM/CGM product from R&D to mass production. Detection Technology Expertise: Proficient in electrochemical/optical blood glucose detection principles (e.g., glucose oxidase/dehydrogenase reactions, three-electrode/two-electrode systems); familiar with test strip material screening/optimization (enzyme carriers, anti-interference membranes); skilled in sensor performance evaluation (linear range, repeatability, stability). Compliance & Standards Knowledge: Thorough understanding of IVD industry standards (ISO 15197:2013, YY/T 1206), medical device QMS (ISO 13485, NMPA GMP), and international certifications (FDA 510(k), CE MDR); hands-on experience with regulatory submissions (technical documentation, clinical trial design). Strong Project Management: Proficient in Agile, Waterfall, or other methodologies; able to coordinate resources efficiently to deliver projects and meet milestones. Strategic & Business Acumen: Capable of integrating technological innovation with market needs to drive commercial success (e.g., market share growth, user cost reduction). Leadership & Communication: Excellent team leadership skills to motivate and develop talent; strong cross-functional communication to align R&D with product, production, and regulatory teams. Deep understanding of the diabetes management field and patient/caregiver needs. Strong learning agility: Quickly master emerging technologies and drive their implementation in products. Resilient & Results-Driven: Thrives in a fast-paced environment, manages multiple tasks concurrently, and maintains focus on objectives under pressure. What's on Offer Competitive annual salary ranging from 1,800,000 CNY to 2,200,000 CNY A permanent role A chance to lead and innovate in a forward-thinking R&D environment. Contact Maria Karp Quote job ref JN-102025-6863583 Phone number +8621 6026 8139 Job summary Function Life Sciences Specialisation Medical devices What is your area of specialisation? Healthcare / Pharmaceutical Location Shanghai Contract type Permanent Consultant name Maria Karp Consultant phone +8621 6026 8139 Job Reference JN-102025-6863583
