FEA Analyst II

BDC Laboratories•Wheat Ridge, CO

About The Position

The FEA Analysist 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.

Requirements

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)
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

Nice To Haves

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)

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.