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Your role:
• 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• 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.
You're the right fit if:
• Bachelor’s 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.
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