Mechanical Engineer

San Jose, CA

Posted: 09/30/2019 Employment Type: Contract Industry: Medical Device Job Number: j-661

Company Overview 

This company is a pioneering medical technology company that puts the patient before the machine. Our human-centered model is designed to dramatically improve not only the care experience – for patients, families, providers and physicians alike – but also cost-efficiency of dialysis delivery. We believe in introducing technology innovation in order to drive service model innovation. And in doing so, we intend to profoundly and permanently impact what, where and who can dialyze. 

Position Overview  

The Contract Staff Mechanical Engineer is responsible for executing mechanical design projects on medical capital equipment, including design development, verification, regression, validation, transfer to manufacturing, and sustaining engineering. The focus of this position is root cause analysis, design change conceptualization, testing, documentation, vendor management, and Design Control. Has a working knowledge of SolidWorks, must be well organized and able to effectively work on multiple projects within a team environment in support of electro-mechanical and fluidic designs with associated documentation. Collaborates and interacts with contract manufacturers, domestic and overseas vendors and other company departments.  

Essential Job Functions 

  • Optimizes existing designs or creates new designs for improved usability, reliability, manufacturability / serviceability, and cost reduction in a cross-functional team environment. Experienced designing machined, formed/stamped, welded, cast and injection-molded parts with cost and ease of manufacturability in mind. 
  • Works with injection molding suppliers to evaluate acceptability of molded parts and corrects designs or processes as needed to produce parts ready for production. Supports vendors during mold IQ, OQ and PQ. 
  • Executes multiple design projects simultaneously, including: root cause of issues, conception and development of solutions, prototyping and bench testing, verification testing, and design transfer to manufacturing. 
  • Uses SolidWorks in the creation of complex models, assemblies, fabrication drawings and assembly drawings.  
  • Knowledgeable with Geometric Dimensioning and Tolerancing standards and their application. 
  • Participates in root cause analysis and troubleshooting activities at the sub-system and component level. 
  • Works with in-house manufacturing, contract manufacturing, vendors and field service engineers to identify issues and opportunities, collaborate on design solutions and drive change. 
  • Analyzes various design requirements and recommends possible solutions or alternate constructions. 
  • Makes various calculations such as strength of materials, mass properties, statics, dynamics, kinematics, stresses, mechanical tolerance stack-ups and statistics. 
  • Uses cost/benefit, FMEA, clinical hazards analysis and other engineering analysis to determine best path to design optimization. Makes data driven recommendations and decisions. 
  • Prepares technical presentations and presents designs to Engineering, cross-functional team members and Risk Management team. 
  • Writes test protocols and reports to provide supporting evidence for proposed changes. Performs testing and/or supervises test technicians in the execution of protocols. 
  • Ensures all necessary documentation is complete such as engineering prints, bills of materials, specifications and manufacturing instructions to allow successful transfer to manufacturing. 
  • Creates Change Orders within the Quality Management System utilizing Agile document control system. Writes clear and concise descriptions of and reasons for change, and justifications for change acceptability. 

Requirements/Qualifications: 

  • A Bachelor’s degree in a relevant Engineering field. A Bachelor’s degree in Mechanical Engineering is preferred. 
  • Must have a minimum of seven (7) years of experience in mechanical design and/or manufacturing of capital equipment.  
  • Medical device company experience is preferred. Experience with low-mid volume capital equipment is ideal. 
  • Self-starter and independent with a hands-on methodology for prototyping and testing. 
  • Experienced with SolidWorks, Solidworks Enterprise PDM and Agile document control system preferred.  
  • Excellent Project Management skills. 
  • Excellent communication skills both verbal and written. 

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. 

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