The R&D Project Manager is responsible for leading cross-functional project teams (internal and external resources) in development of new complex disposable products for use in high flow oxygen therapy. Responsibilities include coordinating, budgeting, and scheduling activities using appropriate project management techniques, technical judgment and interpersonal skills as the associate most responsible for the successful launch of new and innovative sleep 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 Mechanical Engineering, Biomedical Engineering or Plastics Engineering, required.
• Minimum of 10 years engineering experience plus a minimum of 5 years of experience functioning as a Project Engineer performing new product development activities for disposable devices, required.
• Minimum of 5 years of project management experience leading multiple projects with cross-functional teams from initiation to final design and production release, required.
• Experience in sourcing and managing the design and development efforts of external design 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, required.
• Experience 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.