FEA Engineer II

The FEA Engineer is responsible for conducting structural computational modeling and simulations (CM&S) of structural heart and endovascular implants, as well as MRI heating CM&S for a wide range of medical devices. This role requires a driven, collaborative, proactive engineer who thrives on the challenge of working with new innovative medical devices and numerous clients within the medical device industry.

Qualifications:

• Bachelor's degree or Master's degree (preferred) in Engineering
• Experience with FE modeling (5+ years)
• Experience with FE software (Abaqus/Standard)
• Experience with CAD software (SolidWorks®)
• Experience with nonlinear mechanics, fatigue, and plasticity
• Experience in writing CM&S reports (for medical device regulatory submissions, preferred)
• Experience with structural heart / endovascular medical devices (e.g. stents, heart valves) (preferred)
• Experience with multi-physics simulation software (Comsol Multiphysics® software) (preferred)
• Experience with ASME V&V40 (preferred)
• Self-starter with the ability to work independently and as part of a team
• Must be organized, with excellent analytical and problem-solving abilities, and strong communication and writing skills
• Ability to manage competing priorities in a fast-paced environment

Responsibilities:

• Model (modification/generation) of part(s) geometry with SolidWorks®
• Identify the appropriate material model(s) for the medical device and/or physical test configuration under study.
• Develop nonlinear material models, as appropriate
• Identify and ensuring appropriate constitutive relationships for an analysis.
• Work with clients, company subject matter experts, and company engineers to develop boundary conditions that best model in vivo implant conditions
• Perform structural computational modeling and simulations (CM&S) of medical devices and/or physical test configurations using Abaqus/Standard software
• Perform MRI related heating simulations (CM&S) of medical devices of using Comsol Multiphysics® software
• Generate CM&S reports suitable for regulatory submission.
• Managing and executing complex, often urgent, projects.
• Develop and incorporate Verification and Validation practices for CM&S activities following ASME V&V40.
• Communicate clearly with clients regarding required project inputs and deliverables, as well as timelines and progress updates.
• Participate in regulatory inspection activities with regulatory agencies, as needed.
• Participate in the Quality Management System including Document Control, Employee Training, Purchasing and Shipping/Receiving, Work Order Program, GLP Auditing, Corrective and Preventive Actions, Controlled Equipment Management, Internal Audits, Supplier Quality, and Record and Data control.