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Senior Mechanical Engineer, R&D
3 months ago
The individual will contribute in the development of existing and new medical technologies and applications.
Duties and Responsibilities:
· Define and guide development ofelegant mechanical designs that meet requirements for product performance,cost, reliability, and manufacturability.
· Develop designs for all phasesof product development from proof-of-concept through manufacturing.
· Drive design verification by testing design performance in the lab and design validation by developing fast-turn clinical prototypes for use in the research clinic.
· Contribute regularly totechnical design reviews, project scheduling, and development of new productconcepts and applications.
· Use FEA simulation tools tomodel mechanical assemblies and guide design development.
· Other duties as assigned.
Position Requirements:
· B.S. in Mechanical engineeringwith 5+ years related mechanical design experience for capital equipment,laser, or medical devices. Graduate degree a plus.
· Experienced in design of opto-mechanicalassemblies. Experience designing mechanical actuation assemblies such as laserbeam scanning systems, translation and rotation stages is a plus. Knowledge ofstrain-free mounting techniques for optics using adhesives is a plus.
· Strong understanding ofGD&T principles and ability to evaluate and apply them to precisionmechanical designs.
· Proven 10+ years of CAD designexperience. SolidWorks preferred.
· Extensive knowledge of leadingmanufacturing technologies including plastic injection molding, sheet metalmanufacturing, and high precision machining.
· Proven communication skills andability to make design recommendations based on cross-functional inputs(Engineering, Clinical, Manufacturing, Quality, and Regulatory).
· Ability to apply FEA simulationtools to develop designs by correlating simulation results with empirical testdata.
· Basic working knowledge,electronics, optics, and numerical data analysis (Excel, Matlab, orequivalent). Data acquisition skills such as LabView is a plus.
· Familiarity with FDA QualitySystems Regulations/Design Control requirements and their application toprojects from design inception to manufacturing release.
· Knowledge and experience withIEC 60601 compliance standards and ISO14971 Risk Management requirements andtechniques.
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