Key Responsibilities: Define and execute the design and development strategy for renal care devices
Lead the complete product development lifecycle from concept to commercialization Ensure compliance with international regulatory and quality standards (ISO 13485, IEC 60601, US FDA, MDR, CDSCO) Build, mentor, and manage a high-performing cross-functional design and development team Collaborate with clinicians, regulatory affairs, manufacturing, and commercial teams to align product design with market and clinical needs Drive innovation in device design, usability, and technology integration Oversee design control processes, technical documentation, and risk management Qualifications & Skills: Bachelor s or Master s degree in Biomedical Engineering, Mechanical Engineering, or related discipline; PhD preferred Proven track record in leading new product development (NPD) in medical devices, preferably in renal care, dialysis, or critical care Strong knowledge of biocompatible materials, fluid dynamics, sensors, embedded systems, and human-centric design Demonstrated ability to manage design teams and complex product portfolios Experience with regulatory submissions and successful product approvals in multiple geographies Preferred Attributes: Strategic leadership with strong execution capability Technical expertise in medical device design and engineering Strong stakeholder management and cross-functional collaboration Innovation-driven mindset with focus on patient safety and usability Excellent communication and decision-making skills What We Offer: Opportunity to lead the design and development function in a fast-growing renal care medical devices company A collaborative and innovation-driven work environment Competitive compensation and benefits aligned with experience and expertise Job Description
Key Responsibilities: Define and execute the design and development strategy for renal care devices
Lead the complete product development lifecycle from concept to commercialization Ensure compliance with international regulatory and quality standards (ISO 13485, IEC 60601, US FDA, MDR, CDSCO) Build, mentor, and manage a high-performing cross-functional design and development team Collaborate with clinicians, regulatory affairs, manufacturing, and commercial teams to align product design with market and clinical needs Drive innovation in device design, usability, and technology integration Oversee design control processes, technical documentation, and risk management Qualifications & Skills: Bachelor s or Master s degree in Biomedical Engineering, Mechanical Engineering, or related discipline; PhD preferred Proven track record in leading new product development (NPD) in medical devices, preferably in renal care, dialysis, or critical care Strong knowledge of biocompatible materials, fluid dynamics, sensors, embedded systems, and human-centric design Demonstrated ability to manage design teams and complex product portfolios Experience with regulatory submissions and successful product approvals in multiple geographies Preferred Attributes: Strategic leadership with strong execution capability Technical expertise in medical device design and engineering Strong stakeholder management and cross-functional collaboration Innovation-driven mindset with focus on patient safety and usability Excellent communication and decision-making skills What We Offer: Opportunity to lead the design and development function in a fast-growing renal care medical devices company A collaborative and innovation-driven work environment Competitive compensation and benefits aligned with experience and expertise
