Principal R&D Engineer

What you'll do

• Lead new product development, enhancements, and sustaining engineering programs for medical devices.
• Develop and execute design strategies that incorporate FDA, ISO, IEC, and EN regulatory standards.
• Provide technical leadership for 510k submissions and manage complex projects of large scope.
• Write and review technical specifications, protocols, and reports for design verifications and validations.
• Perform risk management and documentation required to satisfy design controls and history requirements.
• Orchestrate finished device and part-level testing to ensure product safety and efficacy.
• Resolve technical issues by implementing solutions through the established Change Development Process.
• Manage the transition of products from R&D to manufacturing environments.

What we're looking for

• Bachelor’s Degree or higher in Biomedical Engineering, Mechanical Engineering, or related field (preferred).
• 4+ years of relevant medical device experience (preferred).
• Proven track record of successful technical project management in a product development environment (preferred).
• Knowledge of medical device design controls and stage gate product development process (preferred).
• Knowledge of mechanical systems, plastics injection molding, and component designs (preferred).
• Experience with CAD, preferably SolidWorks (preferred).
• Manufacturing and Patent experience (preferred).
• Experience with Microsoft Project (preferred).