Mechanical Test Engineer - Medical Devices
Planet Pharma - minneapolis, MN
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Job ID: 615174Our client, a leading Medical Devices company, is seeking a Mechanical Test Engineer for their growing team. This role is involved with medical device testing, test method validation and statistical analysis. See below for other details!Top 3 Skills:Medical Device testingTest method Validation Statistical analysisResponsibilities:Designs, develops, and implements mechanicalelectrical testing methods, fixtures, and equipment based on user needs.Performs test method validation and equipment qualifications per current quality procedures.Performsoversees testing for component and assembly-level devices throughout all product development piles data and performs statistical analyses following current quality procedures (DOE, capability analysis, gage R&R, ANOVA, 2-sample t-test, etc).Effectively communicates test plans and results to key stakeholders.Troubleshoots test failures and proposes efficient and quality-driven solutions.Develops subject matter expertise of product use conditions and applied stresses to products during entire implant lifecycle.Supports animal and human cadaver studies to help define clinically accurate use condition requirements for verification testing or to demonstrate that products meet requirements (GLP study).Provides team leaders with accurate test timeline and cost estimates.Represents test function in project teams; responsible for entire testing deliverables for projects and reporting to project teams.Requirements:Bachelor's Degree (or higher) within an Engineering realm2-5 years of experience in the medical device industryExperience in test development or product development in a highly regulated environmentExperience with test fixture design and materials (3D printing and machining)Experience with Creo, Solidworks, or equivalent CAD softwareExperience with test method validation (TMV), gage R&R, Equipment IQOQ.
Created: 2024-10-06