Founded in 1989, Natus Medical Incorporated is a leading manufacturer of medical devices and software and a service provider for the Newborn Care, Neurology, Sleep, Hearing and Balance markets. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
The Project Manager is responsible for leading and executing projects, with initial focus on a MDR/Remediation Class I project. This position may be based out of Middleton, WI; Schaumberg, IL; or San Diego, CA.
In this job, you will:
- Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
- Ensure that all project deliverables are successfully delivered according to Natus Quality Management System procedures
- Scope, budget, and manage the project
- Plan and execute on milestone plans
- Lead daily coordination of on-site project managers from external partner and internal cross-functional teams.
- Prepare and deliver project communications from team to management
- Ensure that relevant stakeholders are involved accordingly
- Facilitate cooperation between R&D, Product Management and Global Operations in a matrix-like structure
- Manage the suppliers, vendors, and subcontractors on projects where needed.
- Assist in the development and maintenance of product/project documentation required by Engineering SOPs and national/international quality standards and regulations.
- Deliver medical device design documentation compliant with FDA and international design controls and good documentation practices
- Travel: This role does entail a moderate level of domestic and international travel.
- Bachelor's degree in a field of engineering, life science, or other relevant areas required; Master's Degree preferred
- 8+ years of project management experience within the medical device industry
- Great experience with leading remediation projects for medical devices
- Great experience with Design Control
- Knowledgeable of MDR requirements is strongly preferred
- Experience working with hardware/software based product development
- Skilled leader of cross-functional teams with senior specialists and highly skilled employees
- Knowledge across the entire product development process from the concept phase through development, regulatory approval, production setup and launch.
- Strong communication skills
- Basic business understanding and knowledge within the entire product lifecycle value chain
- Proven experience managing multiple projects and/or programs concurrently