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Director of Hardware & Software Engineering

Location:Morrisville, NC
Benefits:Includes Comprehensive Benefits Package
Employment Type:Full Time
Description:The Director of Hardware/Software Engineering is responsible for providing leadership in the direction, planning, strategy and execution of the hardware and software development of new and existing products. This will include all aspects of development including: design, architecture, testing, regulatory compliance and design control.
This individual will be responsible for defining goals, improving processes, managing budgets, directing resources, resolving problems and ensuring strategies that result in cost effective, on-time development of quality products. This position will build and mentor a team of engineers that will support hardware and software development across all product lines.
Duties:• Manages direct reports and provides hands-on leadership to the company’s hardware and software development efforts, whether in-house or sub contracted.
• Responsible for project management activities within the hardware and software development team.
• Create and develop product documentation, including systems, hardware and software specifications, design descriptions, verification and validation protocols, test reports, engineering studies and others as required.
• Facilitate mechanical, hardware, and software integration of new products including complete systems, individual manipulators, instruments and user interface.
• Oversee product design and testing as required by local, national or international safety regulations.
• Responsible for the incorporation of Design for Manufacturability (DFM) and Design for Testability (DFT) principles into product design.
• Supports FDA product approval submissions (510k, PMA) and CE Marking.
• Communicates development status and strategy to the Executive Management Team.
• Establishes an environment of innovation and functions as a source for creative input to solve problems.
• All Other Essential Duties as directed
Qualifications:• Bachelor’s degree in Electrical Engineering, Computer Science or Computer Engineering or any other relevant degree
• A minimum of 10 years of engineering experience in a medical device industry.
• Must have a solid working knowledge of regulatory requirements for software and hardware development, including knowledge of standards such as IEC 60601, ISO 13485, ISO 14971.
• Experience with electromechanical systems integration strongly preferred
• Excellent project management skills and experience with product development from product conception through launch.

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