Director

As a Clinical Product Owner/Scientist in Bangalore with over 10 years of experience, your role involves leading new product development initiatives in Healthcare and Life Sciences. You will collaborate with medical practitioners, OEM partners, and cross-functional engineering teams to drive innovation, solution development, and strategic growth initiatives. Key Responsibilities: - Define clinical use cases, workflows, and user requirements for medical devices. - Identify and validate the needs for new medical devices and enhance existing devices through research and collaboration with medical experts. - Conduct market research and competitive analysis to shape customer market entry strategies and product positioning. - Support system architects and engineers in mapping clinical requirements to features and product specifications. - Provide detailed requirements to Hardware, Software, and Manufacturing teams for developing new medical devices. - Manage the design and iterative development processes to meet customer needs. - Solid understanding of regulatory frameworks such as FDA regulations and ISO 13485 to ensure compliance and product approval. - Author and review Clinical Evaluation Reports (CERs) and support clinical sections of regulatory submissions. - Assess potential risks associated with medical devices and develop strategies to mitigate them. - Assist in managing clinical trials to test device safety and efficacy. - Advise clients on selecting reliable suppliers, optimizing manufacturing processes, and ensuring compliance with GMP. Qualifications Required: - Education: Advanced Medicine degree (e.g., MBBS) or Bio Medical with specialization in Cardio/pulmonary area. - Experience: 10+ years in guiding medical device development. - Technical expertise: Experience in developing ECG/EEG and similar cardio/pulmonary devices, biosensors, electronics, and software design. - Regulatory knowledge: Understanding of FDA 21, EU MDR, and ISO standards (13485, 14971). - Soft skills: Self-driven, research mindset, strong problem-solving skills, critical thinking, analytical skills, excellent communication, and collaboration abilities are essential for success.,