Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.
Position Overview::
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.
What you will do::
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
Skills for Success::
BSME with 8+ years of medical device, mechanical design engineering and product development experience with disposables such as catheters, blood clot removal devices, etc. 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
Numbers & Facts
Location
Plano, Texas
Job Type
Full-time
Skills
3D Modelingunmatched
Analysis Skillsunmatched
Cardiologyunmatched
Catheterizationunmatched
Coagulationunmatched
Corporate Complianceunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Design for Assembly (DFA)unmatched
Document Managementunmatched
Documentationunmatched
Finite Element Analysisunmatched
Injection Moldingunmatched
Laboratory Testingunmatched
Mechanical Designunmatched
Mechanical Engineeringunmatched
Mechanical Testingunmatched
Medical Disposablesunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Medical Treatmentunmatched
Molding Processesunmatched
Oncologyunmatched
Organizational Cultureunmatched
Patient Careunmatched
Product Designunmatched
Product Developmentunmatched
Product Reviewsunmatched
Prototypingunmatched
Quality Assurance Methodologyunmatched
Radiologyunmatched
Regulatory Complianceunmatched
Riskunmatched
Risk Analysisunmatched
Root Cause Analysisunmatched
Safety Trainingunmatched
SolidWorksunmatched
Statistical Modelingunmatched
Statisticsunmatched
System Readiness Review (SRR)unmatched
Technical/Engineering Designunmatched
Testingunmatched
Tolerance Analysisunmatched
Vascular Surgeryunmatched
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