Medical Device Mechanical Test Engineer

Job Title - Test Engineer II

Job Location -Minneapolis, Minnesota.

Duration: 08 Months

Job Description -

• 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.
• Compiles data and performs statistical analyses following current quality procedures (DOE, capability analysis, gage R&R, ANOVA, 2-sample t-test, etc).
• 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.
• Strong technical communication skills both verbal and written
• Experience in test development or product development in a highly regulated environment
• Experience with test fixture design and materials (3D printing and machining)
• Experience in engineering environment with cross-functional engineering teams
• Experience in using engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, or JMP.
• Experience with Creo, Solidworks, or equivalent CAD software
• Experience with test method validation (TMV), gage R&R, Equipment IQ/OQ.
• Lean sigma or DRM (design for reliability and manufacturability) or design for lean sigma training preferred.
• Experience with mechanical test platforms (Instron, and MTS Universal) preferred.
• Experience with fatigue testing (LCF and HCF) preferred.
• Experience with data acquisition and analysis software such as LabView, MATLAB preferred.
• Experience with X-Ray, CT, and MRI image processing software (i.e.,Mimics, 3-Matic, Amira, and 3D Slicer) preferred.