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Outset Medical // improving patient care experience
 
Engineering, Full Time    3052 Orchard Dr, San Jose, CA 95134    Posted: Wednesday, September 22, 2021
 
   
 
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JOB DETAILS
 

Position Overview  

The Sr. Mechanical Engineer Disposables/Consumable Products will play a key role in the the Product Development team to design, develop & improve the disposables/consumable products utilized for the Tablo System. This person will interact with both internal resources, external design houses, suppliers, & Contract Manufactures (CMs) on efforts to develop new designs, improve product quality, increase manufacturing capacity. The Disposables / Consumables Engineer will work closely with cross functional team members to take ideas from concept to implementation. The individual is also be expected to support prototyping, testing, risk management & documentation activities.

Essential Job Functions

  • Leverages experience & knowledge of mechanical engineering, & medical devices to participate in the design & development of Outsets products & intellectual property.
  • Develops new concepts from initial design to market release.
  • Create & translate design concepts into 3D CAD, with emphasis placed on design for low-cost, high volume manufacturing.
  • Works closely with cross functional teams in developing & implementing design solutions. Ability to design with systems perspective. 
  • Design & work in collaboration with cross-functional teams to develop & build benchtop test fixtures. 
  • Perform component, module & system level testing on test fixtures, functional test beds (FTBs), prototype machines & Tablo systems & generate test data. 
  • Analyze data & present/report findings to the engineering organization. 
  • Generate & maintain relevant design documentation, including risk analyses, FMEAs, engineering drawings, theory of operations & system architecture documents. 
  • Contribute significantly to verification testing & validation testing, including generating test plans, protocols & reports, & overseeing test execution. 
  • As a key member of a cross-functional team, ensure smooth transition of new products into manufacturing environment in low-cost global regions. 
  • Performs troubleshooting of component & system level issues identified in R&D, manufacturing, reliability testing & field, including root cause analysis. 
  • Perform any other duties assigned related to product development. 
  • Experience with designing hardware products in an FDA or other regulated industry; comfortable with concepts of design input, design output, traceability, & risk analysis. 
  • Create design solutions utilizing engineering methods with good documentation processes, releasing design documentation through an ECO process. 
  • Interfaces with vendors and/or directs or coordinates prototype fabrication & assembly activities to ensure products & systems conform to engineering specifications; documents designs & manufacturing recommendations. 
  • Define HRS & SYS basing on industry needs. 
  • Approximately 15% travel required, including international.
  • SolidWorks experience preferred. Experience with PDM and/or Agile EC a plus.

Requirements/Qualifications

  • BS. in Mechanical or Biomedical Engineering or equivalent; MS preferred
  • Minimum of 5 years of relevant experience doing product design & development of disposable plastic products in the medical device industry 
  • High level of proficiency on 3D CAD design package, preferably Solidworks, including drafting standards & GD&T
  • Extensive experience & understanding of high volume manufacturing techniques such as over-molding, encapsulation molding, RF welding, ultrasonic welding & other techniques 
  • Basic understanding of data analysis & statistical method 
  • Knowledge of Medical device design controls & project management skills 
  • Strong mechanical, analytical, & technical abilities 
  • Demonstrated knowledge of sound design principles & practices 
  • Demonstrated knowledge of Risk Management techniques & CAPA process 
  • Familiar with working within formal design control processes, writing test protocols & reports 
  • Excellent verbal & written communication with all levels of technical & operating management

Other Skills/Abilities

  • Experience in the Medical Device industry, specifically in high volume consumables. Extra preference given to experience in high volume consumables which physically interface with capital equipment
  • Understanding & experience with blood contacting products, including hemodynamics, flow characteristics & material/geometry biocompatibility
  • Understanding of elementary chemistry & biochemistry
 
 
 
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