Long-term contract position for a Senior Mechanical Engineer supporting new product development of electromechanical medical devices and equipment.
Establish system and component design objectives, author complex specifications and review product requirements.
Develop solutions to difficult analytical and pneumatic, mechanical and electrical design problems.
Conduct conceptual design studies in 3D solid modeling CAD and collaborate across engineering disciplines.
Develop prototypes, test methods, fixtures and prototype tooling using internal manufacturing resources and outside suppliers.
Develop and execute design verification protocols, analyze test data and issue technical reports against environmental, regulatory and safety requirements.
Maintain design documentation within an electronic document control system.
Provide technical direction to junior engineers and serve as lead engineer on small to medium projects.
Requirements
BS or MS in Mechanical Engineering.
Minimum 10 years of related mechanical design and product development experience, including technical supervision of sub-projects.
Experience with CAD software, SolidWorks preferred.
Experience designing electromechanical and electro-pneumatic medical devices or capital equipment.
Working knowledge of DFM&A including cost, tooling and process considerations.
Design experience across injection molded plastics, extrusions, sheet metal, stampings, castings, machined components and additive manufacturing in high part count assemblies.
Working knowledge of GD&T, ANSI/ISO dimensioning and drafting standards and statistical analysis of test data.
Experience with thermal and structural analysis and vibration testing.
Proficiency with mechanical measurement and test equipment including pressure and flow instrumentation, environmental chambers, PC-based data acquisition, multimeters and oscilloscopes.
Knowledge of medical device regulations and quality practices including ISO 13485, GMP and applicable FDA, IEC and UL standards for medical electronic equipment.
