Engineer

Job Description:

• Primary "essential” duties and responsibilities.
• Interprets customer specifications to define requirements for mechanical designs.
• Performs first principal analysis related to appropriate aspects of mechanical design.
• Applies the 3D CAD system to create mechanical design and drawings.
• Develops detailed fabrication and assembly drawings and performs tolerance analysis.
• Develop prototypes for design evaluation.
• Troubleshoot and resolve design & processing issues.
• Contributes to details of design documentation using electronic documentation systems.
• Collects, analyses and interprets data to propose recommendations.
• Develops & execute design verification protocols and technical reports.
• Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies.
• Develop & debug prototype tooling / equipment and processes.
• Develop test methods and fixtures.
• Formulate plans & methods to accomplish assignments with appropriate oversight.
• Works independently and prioritizes assigned tasks with guidance.
• Contribute to project planning activities.
• Train technicians and operators on new process techniques.

Responsibilities:

• Design for Manufacturability and Assembly, DFM&A (cost/tooling/process. considerations), preferably using SolidWorks CAD software.
• Understanding in design and development of injection moulded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable.
• Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable.
• Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data.
• Experience with electronic document control systems in medical device and/or medical equipment design and development.
• Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis.
• Ability to create and meet scheduled timelines (manage and coordinate tasks as required).
• Ability to work in a team environment.
• Strong communication skills.
• Competent in use of Microsoft Office tools.
• Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM's and oscilloscopes.
• Familiarity and the ability to operate basic shop equipment such as hand tools, a drill, and Dremel.
• Understand & interpret simple wiring diagrams.
• Familiarity with Agile Scrum & Waterfall project planning methods.

Requirements:

• BS in engineering discipline, mechanical preferred.
• Minimum 2-4 years related experience, or an MS and less than one year experience.
• Experience with a solid modelling CAD program, preferably SolidWorks.
• Experience in medical equipment / device design with experience in electromechanical, electro-pneumatic, and/or blood pumping equipment development.
• Knowledge in medical device industry regulations and practices – ISO 13485, ISO 7198 & GMP.
• Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat.
• Experience with Microsoft Visio and Microsoft Project preferred.