Job Description
Company Description:
Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Core components of Stereotaxis’ systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com.
Position Summary:
This position is a Mechanical Engineer for the R&D department designing and developing capital and disposable products to support Stereotaxis’ Magnetic Navigation System platform. The ideal candidate will have previously been a successful design engineer with experience in both electromechanical systems and single use medical devices. This role will be a key member of a product development team, working on multiple aspects of Stereotaxis’ unique robotic systems and video display aggregation/consolidation products used in cardiac catheterization labs. The engineer will collaborate with other design engineers, cross-functional project members, suppliers, and partners to realize viable technical solutions and designs for transfer to manufacturing and commercialization. The engineer must excel in a high-energy team environment and be capable of creative problem solving when faced with the time pressures and incomplete information typical of early-stage product development.
Essential Responsibilities:
•Contribute to the design and development of capital systems and single-use medical devices from feasibility through to manufacturing transfer and product launch.
•Perform conceptual and detailed design, analytical modeling, prototyping, troubleshooting and performance testing of devices, systems, subsystems, and components utilizing good documentation practices in accordance with design control processes.
•Create written protocols, test methods, reports, and presentations related to design activities.
•Assist with clinical evaluation of prototypes by supporting ex-vivo and in-vivo Verification and Validation testing.
•Provide hands-on manufacturing assembly work instruction development and refinement (e.g., improvements, cost reductions), and design support to other departments.
•Develop cross-functional relationships with a variety of department representatives (e.g., Quality Assurance, Manufacturing, etc.).
•Must be capable of working independently and in a team, while being flexible and self-motivated.
Job Requirements
Qualifications & Skills:
•Bachelor’s degree in Mechanical Engineering or related engineering field highly preferred, Advanced engineering degree preferred
•3 years of medical device development experience or experience in similarly regulated field
•Experience using engineering skills to develop and take products from concept to production
•Strong creative, analytical, and problem-solving skills, and proven mechanical design experience
•Demonstrated knowledge of component manufacturing processes (e.g., machining, sheet metal, rapid prototyping, injection molding, etc.)
•Mechanical design and analysis skills including statics, dynamics, kinematics, strength of materials, bolted joint analysis, finite element stress analysis, tolerance stack analysis, and statistics
•Proven experience and proficiency using parametric solid modeling and CAD software to design and document parts and assemblies
•Adept at communicating in a collaborative team environment and seeking optimum solutions
•Exceptional mechanical aptitude and strong understanding of design for reliability and manufacturability
•Comfortable with standard mechanical and electrical measurement and test equipment
•Ability to handle ambiguity effectively and oversee multiple projects at once
•Proficiency with SolidWorks preferred
•Experience working in a medical device setting or other regulated field preferred
•Experience and skills in design of high volume (e.g., injection molded) components preferred
•Understanding of mechatronics, robotics, and servo-controlled systems preferred
•Understanding and practical knowledge of geometric dimensioning and tolerancing preferred
•Familiarity with relevant industry standards (e.g., IEC 60601, ISO 13485, ISO 14971, etc.) preferred
•Legally authorized to work in the United States
