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.
