The Engineer, Simulation performs and documents device and instrument simulations related to new product development of orthopedic implants. Knowledge of simulation, biomechanics and engineering principles is applied to evaluate product safety and performance as well as compliance with medical device regulations. The Senior Engineer works under minimal supervision and is part of a cross-functional product development team.
Technical Responsibilities: Perform simulations for design verification and validation of medical devices. This can include analyses using SOMA database and tools, structural FEA, MRI, CFD, Musculoskeletal modeling, or other simulation disciplines.Under minimal supervision, develop or adapt simulation models to fit product evaluation needs and create standard operating procedures.Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.Under minimal supervision, conduct research and studies to support product design.Under minimal supervision, act as a subject matter expert for qualification and validation activities related to general simulation team operations.Under minimal supervision, contribute subject matter expertise and provide guidance and mentorship to Project Engineers, Technicians and Interns.Prepare, perform analyses, and provide guidance to the simulation customers and teams to allow better interpretation of the simulation results, and validation by collaborating with different stakeholders.Perform verification and validation of simulation models and software tools through rigorous credibility assessment in line with the corresponding regulations in collaboration with other stakeholders from test engineering and simulation customers.Perform and consult the team in utilizing CAD software packages and requirements needed for performing the simulation.Partner with project team to foster the use of simulation to design safer and higher performance devices while reducing time and cost.Business Responsibilities: Understand the product's intended use, function and clinical procedures.Take ownership of planning the simulation tasks for projects and manage simulation campaigns.Coordinate and take ownership of the simulation tasks with external partners and assure quality execution of the tasks.Med Device Compliance: Understand fundamental industry standards and testing and simulation strategies which align with regulatory requirements.Assure proper documentation, presentation, and traceability of the executed simulations.Learn relevant Design Control procedure including Simulation, R&D, and Biomechanics procedures and gain an understanding of risk management per the Quality Management System.Become familiar with standardized design verification norms per ASTM/ISO as well as relevant FDA/regulatory guidance.Understand and champion good practices and compliance.General Responsibilities: Under minimal supervision, work with R&D, Product Development, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.Learn procedures, policies, processes, systems, and relevant technology.Demonstrate ownership and integrity of work.Build stable relationships.Contribute to projects as a team member.Technical Skills: Fundamental knowledge and understanding of the corresponding simulation disciplines, e.g. SOMA database and tools, structural FEA, MRI, CFD, Musculoskeletal modeling, or other simulation disciplines and if applicable relevant mechanical testing (and more broadly, device testing) within a regulated environment.Experience in CAD software packages.Basic knowledge of analytical tools and statistical methods.Ability to communicate plans and technical information to team members.Preferred Skills / Engineering tools: Familiarity with the corresponding regulatory requirements, FDA, EU MDR, ISO, ASME, and ASTM.Familiarity with design optimization, sensitivity analysis, model validation, and statistics.Familiarity with applied knowledge of preclinical testing requirements for medical devices according to ISO, FDA, MDR, and ASTM guidelines.EDUCATION REQUIREMENTS: Bachelor or Master of Science or PhD in Engineering, Biomedical Engineering or similar.0+ years of work experience.Fluent in English.MS Office.
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