Test Engineer II
7000 Central Avenue Northeast Fridley, MN 55432 US
Job Description
Additional position details from the manager:
- Can you please confirm your top 3 skills sets required? The ones from the job description that are critical: Medical Device testing, Test method Validation and statistical analysis
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- 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).
- What is your target years of experience? 2-5 years
- When do you plan to start interviewing? As soon as possible
- Will you be looking to hire and start ASAP or will the start date be delayed? Start date would be middle of July
- Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)? Expected to be on site, this team is usually in 5 days a week. We can be flexible and allow some work from home but expect them to be available in the lab everyday when tests are being executed.
ESSENTIAL FUNCTIONS:
- 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.
SKILLS/QUALIFICATIONS
- 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.
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