Senior Mechanical Engineer from Joulé

Title: Senior Mechanical Engineer
Location: Exton, PA- On-Site
Type: Permanent
Start: Asap
 
Overview:
Our client, a research and development-focused medical device company, is seeking a Senior Mechanical Engineer to provide design and technical expertise for assigned development activities, primarily centered on catheter development and innovation.
 
Responsibilities:

• Demonstrate knowledge of engineering principles and its application in solving complex problems.
• Demonstrate working knowledge of product enhancements and manufacturing process refinement.
• Use analysis tools and methods to solve complex technical problems (e.g. CAD, FEA. CFD)
• Demonstrate strong knowledge of materials and processes related to catheter design and manufacturing.
• Generate catheter design concepts and prototypes using specialized hand tools to test their mechanical and electrical properties.
• Assist in the transfer of R&D prototypes builds to manufacturing by developing repeatable and accurate processes.
• Develop and assist in the design of fixtures and tooling used in fabrication and testing of catheter prototypes.
• Support manufacturing activities as needed.
• Generate CAD models and technical drawing files for fabrication in accordance with company drafting standards as applicable.
• Develop design verification test methods and test fixtures to verify catheter functional requirements.
• Lead individual design verification test methods, including writing test protocols, overseeing test progress, providing direct input in test activities and preparing test reports at completion.
• Pre-clinical testing, data collection and analysis of prototype catheters.
• Support activities to enhance IP portfolio of the company.
• Collaborate with outside vendors to obtain quotes, technical information, and purchase materials/supplies and equipment/tooling.
• Technical writing and presentations.
• Create and oversee the preparation of mechanical engineering designs, drawings, specifications, schedules, and cost estimates
• Provide technical assistance to other mechanical engineers and resolve technical issues
• Create validation documentation (IQ, OQ & PQ) and lead the execution of process qualifications for new and existing processes

• Bachelor’s in Mechanical/Biomedical Engineering or related field
• 8+ years of related experience OR Master’s Degree in Engineering and 6+ years related experience.
• Experience with Catheter development
• Demonstrated Solidworks experience or other CAD software tools
• Excellent organizational, analytical reasoning, problem-solving, and conflict management skills

 
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