This position has responsibility of working on project teams to develop orthopaedic products through verification, safety and efficacy, and performance analyses of new products. Orthopeadic products may include Hip, Knee, and Trauma devices and instruments. Analysis methods include Finite Element Analysis (FEA) and mechanical testing. Job responsibilities include addressing moderately defined problems of moderate scope.
Responsibilities: (Please specify % amount against each responsibility) Perform FEA and MRI compatability and safety analysis on medical device components, sub-assemblies, systems, and instruments using state-of-the-art modeling and analysis software (ABAQUS, Unigraphics, and CST Studio Suite). Medical devices may include, but are not limited to, Hip, Knee, and Trauma devices (including screws, plates, IM nails, and External Fixation devices). Development and validation of detailed computational models for due diligence, ideation, concept selection, requirements identification and generation, design evaluation and optimization, and generating design output elements for verification / risk management and regulatory submissions. Perform necessary testing that may include static, torque, dynamic, fatigue, abrasion, fretting, thermal/chemical analysis, hardness, and coating adhesion tests. Testing responsibilities may also include reviewing literature, identifying outside vendors, ordering test parts, designing/preparing test specimens, designing test fixtures, developing test protocols, performing microscopy, taking measurements, analyzing test results, performing data acquisition, statistical analysis, complying with standards, documenting test results, and publishing results per publication plans. Perform administrative functions as necessary including writing reports, maintaining complete and accurate records for all controlled documentation, attending meetings, submitting financial/travel requests, ordering supplies, coordinating team activities, conducting tours and making presentations. Contribute to cross-functional project teams with design-control verification, safety and efficacy, and performance analyses of new products. Perform structural analysis that may include linear analysis strain gage analysis, and dynamic analysis. Analysis responsibilities may also include reviewing literature, reviewing regulatory requirements, preparing specimens, testing parts, performing hand calculations, performing computer simulations, and documenting analysis results. Maintain department standards/compliance by ensuring the use of calibrated equipment, following lab safety protocols, and complying with department manuals and work instructions. Perform testing of orthopaedic products using cadaveric or animal specimens as necessary. Participate in the coordination of clinical, animal and contract studies by reviewing literature, obtaining study quotes, collecting study data and documenting study results.
Education: B.S. or M.S. in Engineering or Science
Licenses/ Certifications: N/A
Experience: Masters of Science in Mechanical or Biomedical Engineering, or other appropriate discipline.
Bachelors of Science in Mechanical or Biomedical Engineering, or other appropriate discipline plus at least 2 years relevant work experience.
Competences: Experience with Finite Element Analysis required.
Must have good team and communication skills.
Requires use of e-mail, Internet and standard Microsoft Office Software.
Must have good time management skills.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and talk or hear. The employee frequently is required to walk. The employee is occasionally required to sit and stoop, kneel, crouch, or crawl.
The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and the ability to adjust focus.
Travel Requirements: 1025%
Associated topics: ansys, automotive, chassis, design, machine, mechanical, mechanical engineer, mechanism, solidworks, turbine