Careers atAgile Search, Inc.

About the Opportunity

This critical hire is with a medical device design, development and manufacturing company specializing in capital equipment and disposable s .  Our client is experiencing tremendous growth and is seeking to expand the senior engineering staff . 

Our client enjoys a close-knit, high-energy culture t hat fosters the creative spirit.   The company offer s tremendous opportunity for professional development and leadership, rewarding projects, competitive salaries, an excellent benefits package, and summer hours. 

We are immediately seeking a Senior Mechanical Engineer with 7+ years of experience in medical product design and development.  Direct experience with complex, electro-mechanical products is a major plus.  BS ME degree or higher is required and an advanced degree is preferred.

R eporting to the Engineering Manager, this individual will lead mechanical design and development activities through all phases of the medical product development process  from the initial design effort, through testing and validation, and on to final manufacturing transfer.

Requirements:  Candidates should have 7+ years of experience with a BSME degree.   A high degree of competence and experience in the design of complex medical capital equipment and disposable devices is required.  Familiarity with appropriate FDA, QSR and ISO regulations: design controls, regulatory approval methods, and overall medical device industry knowledge is critical to success in this role.  Candidate must possess a high level of experience with a variety of manufacturing processes, including injection molding of plastics, machining methods, rapid prototyping techniques, etc.  This role calls for e xpert level skill in the generation of detailed 3D and 2D CAD data (ProEngineer and/or SolidWorks) , with additional experience with GD&T and general dimensioning best practices.  Must have familiarity with FMEA, DFMA techniques, BOM structuring, test protocol writing, verification testing, quality inspection methodology, and report writing. 

In this fast paced environment , our client demands a professional with the ability to manage multiple projects within various disciplines and deadli nes.  High-energy, self-starters only!

Responsibilities: 

• Execute the design and development of complex electro-mechanical medical devices and equipment  
• Develop detail ed CAD design packages (3D data and 2D drawings)  
• Maintain day-to-day communication with program managers and all appropriate program team members  
• Research and procure sample components and develop high-functioning design prototypes  
• Develop and execute prototype testing plans and protocols  
• Stay current with cutting-edge medical device industry and technology trends to ensure innovative product design that will exceed client expectations and succeed in the marketplace