Director

Job Title: Clinical Product Owner/Scientist
Location: BangaloreExperience: 10+ yearsRole Overview:We are seeking a visionary and accomplished Medical Device Clinical Product Owner to lead our new product development initiatives inHealthcare and Life sciences. This role combines deep functional expertise with strong leadership and business acumen. The ideal candidate willhave a proven track record in conceptualizing, evaluating, and developing medical systems. You will liaison with medical practitioners, OEMpartners and cross-functional engineering teams to guide solution development and implementations. This is a customer-facing role with astrong focus on innovation, solution development, and strategic growth initiatives.Core ResponsibilitiesResearch and technology consultation:o Define clinical use cases, workflows, and user requirements for medical devices.o Identify and validate the needs for new medical devices and enhance existing devices through research and through collaborationwith experts in medical fields.o Ideal candidate will conduct market research and competitive analysis to shape customer market entry strategies and productpositioning.Product design and development:o Support system architects and engineers in mapping clinical requirements to features and product specifications.o Provide inputs and detailed requirements to Hardware, Software and Manufacturing teams for developing new medical deviceso Manage the design and iterative development processes to meet customer needs and requirements.Quality assurance and Regulatory Affairs:o Should have a solid understanding of the regulatory frameworks (like FDA regulations in the U.S.) required for the medical deviceand should manage submissions for product approval.o Must have good understanding of quality management systems (e.g., ISO 13485) to ensure the product development processesare as per standards.o Should author and review Clinical Evaluation Reports (CERs) and support clinical sections of regulatory submissions (FDA 510k,PMA, CE Mark, etc.).Risk management:o Should be capable of assessing potential risks associated with a device and develop strategies to mitigate them, ensuring thedevice is safe and effective for end-users.Clinical trials:o Must assist in managing clinical trials to test a device's safety and efficacy, as well as prepare the necessary documentation forregulatory submissions.Supplier and manufacturing support:o Advise clients on selecting reliable suppliers, optimizing manufacturing processes, and ensuring compliance with goodmanufacturing practices (GMP).Required Qualifications and Skills:o Education: Advanced Medicine degree such as MBBS or Bio Medical (preferred specialization in the Cardio/pulmonary area)o Experience: 10+ years of relevant experience in guiding medical device developmento Technical expertise: Experience developing ECG/EEG and similar cardio/pulmonary devices. Knowledge of new medical devicesdevelopment, biosensors, electronics and software design.o Regulatory knowledge: In-depth understanding of regulations like FDA 21, EU Medical Device Regulation (MDR), and ISO standards(13485, 14971).o Soft skills: Self driven, Research mindset, Strong problem-solving, critical thinking, and analytical skills are essential. Excellentcommunication & collaboration are critical for success