Mechanical Test Engineer - Medical Devices

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.