Responsibilities: Plans, organizes, directs and conducts engineering processes to develop new product designs and specifications from concept and prototype through manufacturing and launch. Typical responsibilities include, but are not limited to the following:

• Planning realistic rapid development time schedules.
• Performing complicated engineering assignments involving specification, design, manufacturing, prototyping, launch and revisions.
• Develop CAD models using Solidworks
• Optimize new product designs & specifications through development of engineering drawings to meet regulatory and schedule requirements.
• Provide regular feedback that creates ideas and solutions to decrease time to market and improves new product development process.
• Responsible for entire product life cycle.
• Collaborate with outside fabricators to quote and produce new product prototypes.
• Work with vendors to source new materials.
• Management and development of standards for CAD data system.
• Development of knowledge of applicable regulatory requirements and proper documentation of all activities to satisfy FDA quality system requirements.
• Other responsibilities as business objectives evolve.

• 7-10 years of design engineering experience is REQUIRED.
• Bachelors Degree in Mechanical Engineering from accredited University is required. Master’s Degree in Engineering is preferred.
• Strong project management experience.
• Self-starter with ability to ask questions and deliver assignments under tight timelines with little supervision.
• Strong background in material selection and application.
• Background in medical equipment industry is a plus.
• Hands on mechanical skills and experience in machine shop / prototyping environment.
• Comfortable sourcing vendors for fabrication from prototype to production.
• 3+ Years industry experience with Solidworks 3D CAD platform REQUIRED.
• Proficient in complex electromechanical assembly design.
• Experience designing parts for the following manufacturing processes: Sheet metal General machining Welded frames Injection molding
• Knowledge of loading and safety factor calculations.
• Experience designing experiments to test prototype functionality.
• Experience designing for manufacturability, assembly, and serviceability

An ideal candidate would also have experiences or skills in the following areas:

• Familiar with Document Controls & Document Change Processes
• Familiar with Product Design Verification & Validation Processes
• Expertise with Microsoft Word, Excel and PowerPoint
• Familiarity with meeting regulatory requirements such as UL, IEC, etc.
• Familiarity with FDA quality systems is a plus.