Mechanical Test Engineer

2 months ago


Minneapolis, United States Planet Pharma Full time

Job ID: 615174


Our 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 testing
  • Test method Validation
  • Statistical analysis


Responsibilities:

  • Designs, develops, and implements mechanical/electrical testing methods, fixtures, and equipment based on user needs.
  • Performs test method validation and equipment qualifications per current quality procedures.
  • Performs/oversees testing for component and assembly-level devices throughout all product development phases.
  • Compiles 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 realm
  • 2-5 years of experience in the medical device industry
  • Experience in test development or product development in a highly regulated environment
  • Experience with test fixture design and materials (3D printing and machining)
  • Experience with Creo, Solidworks, or equivalent CAD software
  • Experience with test method validation (TMV), gage R&R, Equipment IQ/OQ.



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