The Role: Individual contributes with limited oversight to the design characterization, verification and risk assessment of implants and instrumentation for the portfolio. This includes communication with multiple disciplines in multiple locations, understanding of applicable industry standards, creation of simulations to replicate standards and communicating results to the global teams. Additionally, the role will involve managing overall workload through put and outsourcing to company offshore resources as necessary.
Essential Functions/Duties and Responsibilities - Under and in accordance with all applicable federal, state, and local laws/regulations and procedures and guidelines, this job/position will:
- Be responsible, with limited oversight, for the computational modeling aspects of Global Lifecycle Management and Line Extensions projects. Activities include:
- Participating on global cross-functional project team through all phases of the product development process,
- Working closely with teams and testing associates to design, execute, validate and report on computational modeling studies
- Author and review reports to meet industry (FDA) & company standards
- Analysis of output using statistical tools and Six Sigma Design Tools (Gauge R&R,DOE)
- Clearly and professionally communicate findings, technical challenges, and proposed resolutions to teams and management
- Assess the effect of design changes on mechanical performance
- Interface effectively with global project teams, management and surgeons
- Manage multiple projects through the ability to prioritize tasks and manage a varied workload as well as offshore resources as needed
- Modify or create CAD models as needed for simulation
- Others duties as requested
Required Education, Training and/or Experience: Bachelor’s Degree in Mechanical/Structural Engineering or equivalent with 3+ years’ experience in structural computational modeling of medical devices or systems preferably in Orthopedics or other regulated industry.
Required Knowledge, Skills, Abilities and Certifications/Licenses:
- ANSYS, LS-DYNA and/or Hyperworks software experience, HFSS a plus
- Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, Project etc.)
- Proficiency in Mini-Tab is preferred.
- Proficiency in CAD preferably Siemens NX (Unigraphics) and/or Creo
- Knowledge of fracture mechanics and/or failure models in computational modeling
- Strong familiarity with material modeling, preferred
- Familiarity with statistical methods, design optimization and experimental design, preferred (Gauge R&R and DOE)
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, and test equipment
- The ability to review and critically assess computational modeling documentation and laboratory documentation is a must.
- Must be able to collaborate effectively in a team environment and be able to effectively communicate highly technical information to a diverse audience
- Must be highly organized, able to work on concurrent projects, coordinate work with offshore resources to meet tight deadlines
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