Mechanical Engineer

Pleasanton, CA

Posted: 06/17/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008734

PURPOSE OF JOB  
  
This company is an early stage medical device company specializing in the development, manufacture and distribution of product lines that may gently accelerate orthodontic tooth movement with either braces or aligners and may also reduce the painful side effects associated with treatment. Patients achieve these results in a simple 10 minute per day treatment utilizing harmonized mechanical, electrical and software systems.  
  
In this position, the Mechanical Engineer retains responsibility for defining and implementing mechanical designs to create a robust / easy to use products compliant with international Medical Device design standards and requirements. The ideal candidate has obtained design experience across a diverse set of mechanical components including, plastics, injection molding, sheet metal, silicone molding, packaging and electronics (PCBA’s, Flex PCBA, Battery, Etc.)    
  
KEY DUTIES AND RESPONSIBILITIES  

  • Serves as a technical resource to translate industrial design concepts into functional product 
  • Participates within, identifies and documents design requirements for mechanical systems 
  • Retains full responsibility for delivering a complete mechanical packages including solid models, 2D specifications and off the shelf specification development, etc. 
  • Leads the development of mechanical system requirements compliant with applicable regulatory and international standards 
  • Leads and conducts applicable Validation and Verification, reliability, accelerated aging and certification (CE Mark) activities 
  • Supports the identification, bring-up and qualification of suppliers 
  • Serves as a member of cost reduction teams to achieve established COGS targets 
  • Implements DFM / DFX inputs to drive increased cost and quality efficiencies   
  • Designs and implements testing tools for the use in R&D development and scaled manufacturing operations. 
  • Analyzes equipment and operating data, conducts experimental tests, evaluates results and provides recommendations for implementation 
  • Serves as a primary investigator to perform mechanical failure diagnostics and implements solutions for systemic issues 
  • Conducts feasibility studies and testing on new and modified designs. 
  • Directs support personnel (technicians) in the preparation of detailed design, design testing and prototype fabrication. 
  • Performs other duties as assigned  

QUALIFICATIONS and EXPERIENCE REQUIREMENTS  

  • Bachelor’s Degree in Mechanical Engineering or equivalent experience; Master’s degree preferred. 
  • 8+ years of related experience.   
  • Previous Medical Device design experience 
  • Experience with electromechanical devices in a mid to high volume production setting.   
  • Must be extremely proficient in CAD (strong preference for Soldworks).   
  • Experienced in the design and fabrication process associated with of silicone molding, printed circuit board assemblies (footprint), thermoplastics (via injection molding), over molding (thermoplastics and silicone), sheet metal and packing 
  • Experience in developing waterproof designs compliant to IPX 7 standards. Specific expertise in snap and gasket design strongly preferred. 
  • Electronics experience highly desired (Rigid / Flex PCBA) 
  • Experience with LabVIEW or other similar software strongly preferred 
  • Experience in light path analysis and optimization strongly preferred 
  • Familiarity with the following standards / regulatory requirements: ISO 13485 (Medical Device Quality Management Systems) 
  • ISO 10993 (Biocomp)   
  • ISO 14971 (Risk Analysis) 
  • IEC 60601 (-1, -1-2, -1-11, 2-57) 
  • IEC 62366 (human factors), 
  • IEC 60601-2-57 (Safety and Performance of non-lasar light source, IEC 62471 (Safety of lamps and lamp sources) 
  • ISTA 2A & 3A (Packaging and transportation) 
  • ANSI 
  • ASME 
  • FDA QSR Part 820 
  • MDD  

OTHER REQUIREMENTS  
  

  • Thorough working knowledge of the medical device industry   
  • Hands-on, self-starter with desire to work in a fast-paced start-up environment (thrives on action) 
  • Goals and objectives oriented with emphasis of project completion within established time and cost requirements 
  • Critical thinker and uses data to support recommendations and actions 
  • Ability to travel (~ 30%) • Thorough working knowledge of personal computer systems and desktop office applications, including Word, Excel, and PowerPoint 
  • Excellent verbal and written communication skills  

PHYSICAL DEMANDS   
  
General office work – computer work, standing, sitting, bending, lifting up to 25lbs. 

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