BDC Laboratories · 6 hours ago
FEA Analyst II
Wheat Ridge,CO,US
Full-time
Onsite
Senior Level
$125K/yr - $150K/yr
5+ years expBDC Laboratories is seeking an FEA Analyst II to conduct structural computational modeling and simulations for medical devices. The role involves working collaboratively on innovative medical devices, managing projects, and ensuring compliance with regulatory standards.
Mechanical Or Industrial Engineering
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
Qualification
Required
Bachelor's degree or Master's degree 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
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
Preferred
Experience in writing CM&S reports (for medical device regulatory submissions)
Experience with structural heart / endovascular medical devices (e.g. stents, heart valves)
Experience with multi-physics simulation software (Comsol Multiphysics® software)
Experience with ASME V&V40
Company
BDC Laboratories
BDC Laboratories has been a leading service provider for the medical device industry for over 40 years – specializing in comprehensive ISO/IEC 17025:2017 accredited testing services, testing equipment, simulated use solutions, and silicone mock vessels and anatomies.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Stefan Stemmer
CEO BDC Laboratories
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