POSITION SUMMARY:

This position will contribute to the company success through the management of cross-functional team activities in product development and research and development. The individual will work on product development projects to design, build, and test medical devices.  These devices may include radiofrequency ablation, cryo ablation and nerve block, left atrial appendage management, or capital equipment systems and devices that are used by cardiac surgeons, thoracic surgeons, electrophysiologists, and other clinicians.  This position collaborates with project teams, production associates, external vendors, leadership and other work groups to achieve the company’s goals of producing market-leading products through positive patient outcomes. The role will have direct reports and will work with other teams/vendors to achieve the project goals. 

 

ESSENTIAL FUNCTIONS OF THE POSITION:

Manage cross-functional team activities within a technology or product platform such as radiofrequency ablation, cryogenic ablation, left atrial appendage management, or capital equipment, including development, technology, schedule, resource utilization, budget, and performance validation Coordinate system development tasks to include design, integration, and formal testing of products and devices Manage cross-functional team activities including technology, development, schedule, resource utilization, budget, and performance validation Generate and manage overall development planning tools including critical specifications (Design Plan, Quality Plan, etc.), management tools (Project Schedule, Tooling / Part / Fixture tracking forms, V&V matrix, etc.) and communication tools (Weekly meeting template, team norms, etc) Develop and complete actions in product specifications, technical and logistical requirements, and other disciplines Develop a rapport with key customers – surgeons, nurses, and other clinicians Develop in-depth understanding of clinical procedures and techniques applicable to AtriCure products Create and maintain programmatic and technical documentation to insure efficient planning and execution Aligns and coordinates resources, priorities, work plans, and activities among outside suppliers and the AtriCure Research & Development group Determines work procedures, prepares work schedules, and expedites workflow Communicate with and direct external suppliers of components, subassemblies and finished assemblies Generate and document intellectual property Review and authorize engineering design changes Develop component and product technical specifications including the integration and consideration of applicable standards and regulations Establishes methods and procedures for new or special assignments that require functional expertise and takes initiative to resolve issues. Establishes operational objectives and applies knowledge and industry best practices to achieve primarily operational or functional results. Consistently identifies and reconciles multiple issues, opportunities, and solutions; drives and communicates the agenda throughout the organization. Mentoring of other engineers

 

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

Regular and predictable worksite attendance Ability to work under fast-paced conditions Ability to make decisions and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned

BASIC QUALIFICATIONS:

BS degree in Engineering 5+ years in medical device engineering (product development) Electrical Engineering experience Requires understanding of complete development horizon including needs assessment, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validation Requires strong engineering skills and active participation in the technical advancement of the programs. Ability to read technical specifications, blueprints, and drawings Able to manage cross-functional team activities including technology development, schedule, resource utilization, budget, and performance validation Understanding of program management tools and expectations of medical device design and manufacturing controls Knowledge of Design Controls and experience with FDA QSR 21 CFR Part 820 and ISO 13485

 

PREFERRED QUALIFICATIONS:

7+ years of medical device engineering experience (product development) Experience mentoring or managing junior engineers Demonstrated ability with data analysis, problem-solving, and troubleshooting Demonstrated understanding of industry regulations as it pertains to medical devices Demonstrated understanding of external standards, design controls, quality controls, manufacturing methods Demonstrated a high level of accountability and results for self and team

 

OTHER REQUIREMENTS:

Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to regularly lift up to 25 pounds, occasionally lift up to 25 pounds Ability to pass pre-employment drug screen and background check

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