Job Description
**Medical Device R&D Project Manager** A seasoned project manager is sought to lead technical projects in a leading medical device R&D company, overseeing planning, scheduling, budget management, and resource allocation. **Job Description** Reporting to the Senior Director of Device Engineering, the successful candidate will lead technical projects, ensuring all activities adhere to design controls and meet technical quality, reliability, schedule, and cost requirements. Key responsibilities include: * Providing leadership and centralized management for the planning, development, and execution of technical projects * Managing multiple, concurrent projects, consistently meeting expectations * Making difficult decisions regarding project priorities, ensuring team and leader buy-in * Overseeing all phases of project execution, including stage gate reviews and design reviews * Leading project team members in using established PM tools and techniques to stay within budget and achieve project and organizational objectives * Conducting risk assessments for technical and project-related issues, developing mitigation plans to maintain project schedules and costs * Innovating and contributing to the development of the organization through the application of technical knowledge * Developing methods, procedures, and metrics for projects (scope, schedule, quality, and cost) and reporting * Monitoring and controlling implementation plans according to defined scope * Ensuring the successful execution of significant technical projects, maintaining a clear focus on life cycle costs **Requirements** * A minimum of 8 years' experience in project management, with a proven track record in: + Applying project management tools to manage product development projects + Building, managing, and maintaining business partnerships + Applying knowledge of ISO standards and FDA Design Control regulations * Experience in developing complex, sophisticated software-controlled electromechanical medical devices with verification & validation activities is a plus * Experience in developing complex sterile disposable medical devices, including plastic injection molding, extrusion, and assembly methods, is a plus * Experience in outsourced medical device manufacturing, manufacturing technologies, and process development is a plus * BS in engineering or a technical field with 8+ years of product development (medical device engineering) and 8+ years of applicable project management experience in medical devices, healthcare, or pharma development environments * Possess interpersonal skills to negotiate and reconcile differences while optimizing overall business goals * Excellent written and verbal communication skills with strong competency in MS Office tools and project management applications * Certification in Process Excellence (Green Belt or Black Belt) or project management certification PMP is a plus