Staff Mechanical Engineer

*This position is located on site in Mason/Cincinnati OH Must be able to commute or relocate for this position

POSITION SUMMARY:

This position will work on projects of significant and diverse scope and will be responsible for applying technical expertise to meet the organization’s business objectives. They will work on project teams that are responsible for producing next generation medical devices to be used by electrophysiologists and cardiac surgeons. The successful candidate will have technical capabilities in concept development, design, prototyping, testing, and intellectual property generation. They also will have shown the ability to conduct research and development activities and exercise independent judgement to clarify and prioritize tasks to facilitate team decision making. They must also have demonstrated success at fostering relationships with internal stakeholders, external suppliers, and key opinion leaders. Performance in this job requires an understanding of cardiac clinical practices and procedures. Experience with FDA and Regulatory requirements and standards is required.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Participate in Voice of the Customer planning, collection, and analysis
• Obtain input/ feedback from key customers – surgeons, nurses, and other clinicians 
• May lead or support variety of engineering design and development tasks, to include design, analysis, material selection, prototyping, in-vivo and in-vitro testing, and user validation
• Use Geometric dimensioning and tolerancing (GD&T) to define and communicate the nominal geometry and tis allowable variation on engineering drawings and models.
• Develop and validate test methods for new product features and functions
• Define methods and develop processes for assembly of new products 
• Communicate with and direct external suppliers of components subassemblies and finished assemblies
• Assist with technical development efforts, specifically the design of medical devices, material assessment and selection, testing and analysis, verification, and validation
• Conduct risk management for proposed technical approach, define risk mitigation plans, and execute
• Lead requirement Gathering, FMEA and risk analysis activities
• Generate and document intellectual property
• Support the development of the overall AtriCure product portfolio including procedural needs and technology solution definition
• Mentor more junior engineers or co-op students
• Stay current with latest relevant technology through literature, seminars, and conferences

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

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

BASIC QUALIFICATIONS:

• BS in Engineering: Mechanical, Electrical or Biomedical Engineering is preferred.
• Minimum eight (8) years experience or MS degree with minimum six (6) years experience
• Strong knowledge and experience in requirement gathering, FMEA, and risk analysis.
• Use of design and simulation software such as SolidWorks, Altium, MultiSim, COMSOL, etc.
• Experience in developing prototypes and Design for Manufacturability.
• Experience in the development of Process Flows, Control Plans, Design of Experiments, Measurement
• Systems Analyses, and Process Capability Analyses.
• Demonstrated initiative to solve complex technical problems
• Be comfortable collaborating with clinicians to identify unmet needs and solutions.
• Outstanding written and verbal communication skills
• Ability to travel 20%

PREFERRED QUALIFICATIONS:

• Master’s degree in Engineering
• Medical device design experience
• Knowledge of Change Order Systems
• Experience with C, LabView or similar software languages
• Prior experience developing RF Generators
• Knowledge of cryo ablation systems a plus

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 over 50 pounds
• Ability to pass pre-employment drug screen and background check

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