Senior Mechanical Engineer

Argon Medical Devices Inc•Plano, TX

12h

About The Position

The Sr. Mechanical Engineer performs and owns all aspects of new and existing medical device product design, drawing, development, costing, manufacturability, optimization, Engineering confidence testing, packaging, and design control documentation with adherence to all applicable standards from conception to launch.

Requirements

BSME required
8+ years of medical device design and product development experience required
SolidWorks and FEA. Mold flow analysis is an advantage
GD & T, Detailed drawings, Tolerance analysis
Ability to implement DFM and DFA principles into product design and conduct risk analysis
Knowledge of standard laboratory test methods for mechanical functional parameters
Ability to perform root cause analysis using both experimental and statistical analyses
Knowledge of plastics and injection molding

Responsibilities

Establishes requirements and assures product conformance through appropriate inspection and test activities.
Review product / system requirements and create new concepts for mechanical design of new product or enhance the design of existing product as required and own the development process from concept to launch.
Develop mechanical design to product specifications in compliance with company standards, procedures, specifications, and codes.
Design and develop tolerance stack analysis using 3D modeling and statistical tools. Support the design control process with necessary documentation like DFMEA, Impact analysis.
Prepares layout and detailed drawings including all required fits, dimensions, section views and parts lists/BOM
Conduct complex FEA, as needed, to ascertain the design conforms to the functional and safety requirements.
Conduct complex DFMEA and develop design controls to mitigate the product level risk.
Investigate new materials and incorporate complex DFM and DFA principles into product design
Perform mold flow analysis to ascertain the part design accommodates all injection molding process requirements.
Lead design reviews for systems robustness and Design for Manufacture and Assembly (DFMA)
Perform root cause analysis to resolve design anomalies and incorporate design changes as necessary
Work with external vendors to build prototypes and evaluate performance. Perform ECT testing together with the V&V team, guide the test team as an SME