Clinical Development Manager

Pursuant to section 20 C.F.R. * 656.10(d), this notice is being provided as a result of the filing of an application for permanent employment certification for an alien worker with the Department of Labor for the following job opportunity:

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; and
• 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; and
• 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; and
• 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; and
• 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; and
• Manage teams and cultural dynamic across U.S. and India.

We require a Master's degree in Biomedical Engineering, Biomedical Innovation, or a closely related biomedical field. The position requires at least 5 years of experience in medical device development, including working with physiological vitals, planning and executing clinical trials for continuous noninvasive blood pressure features, complying with international standards regulations (ISO, IEEE, ANSI) towards medical device development, designing control requirements (ISO 13485, IEC 62304), designing and maintaining SOPs and DHFs to comply with FDA guidance, and managing 510K project submissions. We also require at least 5 years of experience with: regulatory requirements for cardiovascular and vital signs monitoring devices; verification and validation activities; working in Matlab and Linux based system; clinical data management, project planning, managing scope, and project timelines (Smartsheet); and managing deliverables in quality management system (Greenlight Guru, IMSXpress. Travel approx. 10% to conduct clinical study activities across the U.S. Partial telecommuting from home may be allowed but must reside within normal commuting distance from the office.

Murata Electronics North America, Inc., 700 Commerce Dr., Stet 190, Woodbury, MN 55125

$178,589/year and benefits including insurance (medical, dental, vision), 401(k) employer match, paid time off, tuition reimbursement, flexible and health spending accounts, and more.

Any individual may submit an application to the following individual for consideration for this position:

EMPLOYER NAME/CONTACT: Please apply online at https://jobs.murata.com/Vios or send resume to Kristen Kosel, 700 Commerce Dr., Stet 190, Woodbury, MN 55125 or kristen.kosel@murata.com.

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer of the Department of Labor. Addresses: U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Ave NW, Room N-5311, Washington, DC 20210.