Qualifications:

• BSME or equivalent experience (8-10 years’ of product development experience)
• Fluency with SolidWorks, PDM and PLM software
• Strong knowledge of Geometric Dimensioning and Tolerancing, Tolerance Stack Analysis, standard drafting and documentation practices
• Experience designing complex electro-mechanical products and assemblies consisting of mechanisms, motors, gears, actuators, chassis, frames, weldments, sheet metal skins, packaging design, tools and fixtures
• Strong knowledge of fabrication processes such as machining, casting, injection molding, stamping, brazing and anodizing
• Familiarity with standard materials for part fabrication – aluminum, steel
• Familiarity with quality standards ISO 9001, ISO 13485, CFR 21 Part 820

Responsibilities:

• Generate CAD models and drawings in accordance with company standards based on input and direction from engineers. Verify all work and document materials and quantities needed for products/components
• Design and develop mechanisms, drive trains, user interfaces, and mechanical and electrical packaging solutions appropriate for the project
• Anticipate problems in manufacturing, assembly, installation, and operations, ensure questions are resolved in the drawings produced.
• Work closely with suppliers to optimize cost and lead times for parts.
• At higher levels, assist the team in the planning, scheduling, costing, and coordination of internal and external resources of projects.
• Maintain accurate documentation of concepts, designs, specifications, drawings, and processes consistent with QSR and FDA requirements. Document risk assessment, verification, validation, test results, and analysis in accordance with FDA design control requirements.
• At the more senior level, provide mechanical and technical expertise and creativity for products designs intended for both domestic and international markets.
• Provide support for the resolution of product complaints and/or safety issues.
• Work with project management, engineering, manufacturing, marketing, quality, and regulatory staff to coordinate pilot production of new products.
• At higher levels, train and instruct other members of the department and the company, by passing along skills and information to assist them in their development.
• Become an independent employee able to analyze problems and formulate plans to overcome challenges and to get work done quickly with a high degree of quality. Make sound and logical decisions and choose the appropriate courses of action based on the parameters of the situation at hand and use continual improvement problem solving skills.
• Create an ongoing effort to improve the company and the R&D Department through personal action and by contributing creative ideas to support both the department and company’s ongoing improvement efforts.