Assures the development of multi-level project planning to achieve short and long-term business objectives
Develops, tracks and reports on all key product development and regulatory compliance programs.
Keeps leadership team informed of design/development progress and issues.
Develops and communicates key performance indicators (cost/schedule/resources) for projects.
Provides cross functional teams with appropriate updates to perform assigned tasks.
Interfaces with appropriate internal and external resources to ensure on-time delivery for projects.
Interfaces with cross functional teams (regulatory, quality, R&D, systems engineering, manufacturing, supply chain etc.) to ensure programs meet divisional goals.
Guides development and documentation in line with QMS, standard operating procedures, specifications and test procedures.
Participates in review boards for CAPA, complaints, business unit planning, and others as necessary.
Reviews and provides functional approval for project and quality system documentation.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Proven experience working independently, leading and driving project deliverables while holding project team members accountable.
Demonstrated proficiency of project charter, schedule/critical path management, budget, scope and risk management using the Project Management framework- PMBOK/PMI guidelines
Bachelor's Degree in a technical field (i.e. Sciences, Engineering) or related discipline
5+ years of medical device development experience and managing complex, multi discipline (electrical, software, mechanical) devices
Managed cross discipline (Clinical, Regulatory, Operations, R&D, etc.) development teams.
Working knowledge and experience with 21 CFR 820 and European Medical Device Directive IVDD/IVDR (application to medical devices) and CE mark
Proficient with MS Project, Excel, and PowerPoint
Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization