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
Requirements: 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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System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.