Clinical Development Manager

Clinical Development Manager

Murata Electronics North America, Inc. seeks a Clinical Development Manager in Woodbury, MN, to manage the medical device product development activities with the following duties and responsibilities :

• Algorithm development for medical devices.
• Translate research specifications and prototype codes into product design specifications and requirements.
• Design and develop software and firmware architecture for the product in development.
• Create test methods, perform design verification and validation activities for medical device products in development.
• Create protocols for data collection used for algorithms.
• Plan and maintain documentation with the team for the phases of product development.
• Support continuation engineering team in resolving bugs and field issues by :
• Perform root cause analysis, change and implement designs;
• Test and document each resolved issue.
• Ensure compliance with all necessary design and regulatory standards related to design, security, and quality of key product and service systems.
• Manage the product design iteration process cross-functionally.
• Provide key contributions on clinical insights to the product development team;
• Manage business and technical requirements for developing and executing a comprehensive service experience for Vios customers, including developing and communicating service requirements to development teams and external service partners; continuously monitoring and revising projects to ensure quality services development and that project milestones and deadlines are met.
• Manage communication with other teams and external stakeholders.
• Work with key subject matter experts, physicians, other stakeholders to identify clinical goals and translate them to system requirements;
• Confer with internal and external project personnel to manage problem identification and resolution;
• Act as subject matter expert (SME) for assigned products and services; and manage communication with team and key Vios management.
• Manage project plans, budget and execution.
• Develop project plans for the system and sub-system project plans and services, including project objectives, specifications, schedule;
• Establish sub-team priorities based on organization goals and monitoring and tracking the project milestones and deliverables;
• Develop research plans and performance metrics for the pre-clinical assessment of the clinical features;
• Provide data-driven feedback to the design team;
• Manage teams and cultural dynamic across U.S. and India.