BS or MS in electrical engineering, computer science, biomedical engineering or related field 8+ years of experience with product development activities, preferred in a regulated environment. Experience with requirements authoring design, trade-off analysis, systems integration, risk management and V&V processes. Proficiency in technical documentation, risk assessment and design control processes. Knowledge of Software and System Architectures and design principles. Experience using configuration management, test management, requirements management, and issue tracking systems. Ability to lead teams through a structured approach to solving complex technical problems. Strong knowledge of Design Controls & Risk Management practices Strong personal credibility & excellent communication skills Ability to work cross-functionally and communicate technical insights effectively Experience leading product development teams in a Medical Regulated Environment. Experience in building and modifying System Architectures, Systems Requirements, Systems Design for implantable medical devices and connected platform eco-systems. Knowledgeable in Human Factors and Usability Engineering processes as part of regulated product development. Demonstrated ability to interact with and influence key stakeholders both internal and external to the organization. Experience dealing with regulatory questions from FDA, BSI, TUV