Project Specialist III

Project Support: Assist in overseeing various aspects of new medical device product development projects, from initiation through to commercialization, ensuring alignment with project goals, timelines, and budgets. Cross-Functional Collaboration: Work closely with R&D, process development, engineering, regulatory affairs, quality assurance, and manufacturing teams to drive project progress and ensure seamless communication across departments. Process Development: Provide support and guidance on process development activities, including design verification and validation, prototype testing, process optimization, and scale-up activities to support product commercialization. Risk Management: Conduct risk assessments and assist in developing mitigation strategies to minimize project risks and ensure compliance with regulatory standards (e.g., FDA, ISO). Documentation and Reporting: Maintain thorough and accurate project documentation, including project plans, status reports, meeting minutes, and regulatory submissions as required. Quality Assurance: Ensure adherence to quality standards and regulatory requirements throughout the project lifecycle, participating in design reviews and quality audits as necessary. Budget Oversight: Monitor project budgets and expenditures, identifying cost-saving opportunities and managing financial resources effectively. Continuous Improvement: Support process improvements and best practices to optimize project management processes and enhance overall efficiency and effectiveness. Stakeholder Engagement: Communicate project status updates, milestones, and challenges effectively to stakeholders, including senior management, ensuring alignment with strategic objectives. Bachelor's degree 3+ years of Project Management experience Strong organization, communication and influencing skills Results-oriented and focused on delivering timely, accurate and premium execution Demonstrated experience in building relationships across a network of people and functions Systems experience with Ariba, Windchill and SAP Sterilization, Climatic and Distribution processing experience Working experience within Electrophysiology Process Development teams