Additional position details from the manager:

1. 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
2. Designs, develops, and implements mechanical/electrical testing methods, fixtures, and equipment based on user needs.
3. Performs test method validation and equipment qualifications per current quality procedures.
4. Compiles data and performs statistical analyses following current quality procedures (DOE, capability analysis, gage R&R, ANOVA, 2-sample t-test, etc).
5. What is your target years of experience? 2-5 years

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.