The Project Manager is responsible for leading cross-functional project team (internal and external resources) in development of new complex electromechanical and hardware for respiratory therapy. Responsibilities will include both New Product Development and Sustaining Engineering activities as required.
Responsibilities include coordinating, budgeting, and scheduling activities using appropriate project management techniques, technical judgment and interpersonal skills. As the associate most responsible for managing launch of new and innovative Acute Care and Home Care products. The successful candidate will actively lead and participate in periodic project meetings, design reviews, and R&D reviews, preparing and communicating project overviews and status reports to executive management.
• Work with marketing, regulatory, quality assurance, and clinical personnel to assure product specifications are set appropriately
• Develop and assure compliance to project goals, including schedule milestones, cost targets, and product quality.
• Proactively identify and mitigate project risks.
• Track all issues and action items to closure.
• Assure project teams follow good engineering practices and Quality System processes.
• Effectively use project management systems to achieve project deliverables relative to safety, effectiveness, usability, manufacturability, reliability, cost, quality, and time to market
• Bachelor of Science degree in Software Engineering and/ or Electrical Engineering, required.
• Minimum of 10 years engineering experience plus a minimum of 5 years of experience functioning as a Project Manager leading multiple projects with cross-functional teams from initiation to final design and production release, required.
• Experience managing the external design and development firms, required
• Experience with integrating / transitioning new product ideas into cost effective, high production yield, and easy to manufacture products, required.
• Experience utilizing a disciplined, structured, and repetitive product development life cycle process, required.
• Experience in providing effective tools for communicating project priorities, issues, risks, milestones, and status and utilizing project management software and tools, such as Microsoft Excel, Microsoft PowerPoint, and Microsoft Project, required.
• Understanding of FDA, MDD, and ISO Quality System Requirements (including safety and regulatory testing) and their application within a medical product development environment, required
Vapotherm - 30+ days ago
Vapotherm, Inc. is a privately held manufacturer of respiratory care devices for hospitals and home care use based in Stevensville, Maryland...