Show technical leadership and responsible for realization of full software product release/life cycle management to ensure quality and compliance Translation of business requirements, user requirements, and clinical use scenarios into software product/system requirements. System decomposition and allocation of derived requirements down to SW element and unit level and related traceability. Evaluate trade-off of software design specifications and interfaces, determine feasibility of potential solutions, and lead technical design reviews. Ensuring full Product Safety Risk Management to satisfy regulatory requirements. Lead risk management activities like Failure Modes and Effects Analysis (FMEA) to identify design issues and lead the team in developing mitigations to address these issues. Elicits, reviews, and characterizes stakeholder feedback; creates and reviews software system-user interaction model with various Systems Engineering related Methods/tools. Responsible for the integration of various software sub-systems to ensure the product meets user and product level requirements through verification and validation. Work with cross functional teams like Marketing, regulatory, quality, project management, systems test to ensure the successful execution of programs.
Youre the right fit if: bachelors degree in engineering or a related discipline. 8+ years of professional engineering experience. Experience working in new product development. Experience with systems engineering tools like use scenarios, systems modeling. Experience performing risk management and Human Factors engineering. Experience with requirements management tools like Jama, Polarion, IBM DOORS etc Experience with regulatory standards like IEC 62304, 82304, ISO 13485, ISO 14971.