Director of Engineering

Primary Responsibilities

• Department management
• Engineering resource hiring, management, and allocation
• Development or improvement of systems and processes
• Execution of client projects
• Status reporting on client projects
• Work output quality and professionalism
• Business development support

Qualifications

• Proven experience in Engineering Management and Team Leadership
• At least 15 years of experience, and at least 5 years in a department or group leadership role
• Advanced written, spoken, and interpersonal communication skills
• Medical device development experience, including ISO 13485 and FDA QSR 820 compliance, and implementation of design controls during development
• A working understanding of the primary engineering disciplines, including mechanical, electrical, firmware, software, and manufacturing engineering
• Product development experience from inception through transfer to manufacturing
• Experience with the adaptation and implementation of project management systems, including the selection of software tools for managing hardware and software projects, integration processes, and methodologies
• Strategic thinking and decision-making capabilities to align engineering initiatives with company goals
• BS/MS degree in an Engineering or a related field
• Familiarity with products from low- to high-complexity that include hardware and software, consumables, and single-use disposables
• Familiarity with low- to high-volume product designs that utilize a wide variety of manufacturing methods
• Experience scoping projects and creating both labor and non-labor cost estimates, project schedules, and development plans