Mechanical Engineer

Bay Area
Apr 17, 2018
Required Education
Bachelors Degree
Position Type
Full time


The Mechanical Engineer is responsible for the design, development, improvement of, launch and documentation of complex, high speed assembly equipment used for the production of medical diagnostic disposables.  The successful candidate will be responsible for system specification, machine tooling and fixture design, as well as continuous improvement efforts on existing machines to improve reliability, throughput, uptime and safety. Hands on and supervisory experience of automated equipment assembly, electro-mechanical equipment and mechanical prototype fixtures is required. The position also requires interacting with contract manufacturers for outsourced projects.


  • Responsible for the mechanical design and development of automation projects including user requirements, test plans, prototype material procurement, assembly, testing and final production release
  • Contribute to the definition and design of the system architecture, ranging from simplified block diagrams, to the detailed architecture
  • Create documentation including, but not limited to, design input requirements, specifications, design of experiments, assembly and service procedures
  • Author acceptance test and validation protocols and reports
  • Lead own design reviews for all steps of design process
  • Selection and specification of machine components such as motors, pneumatics, solenoids, conveyors, part feeding components and hardware
  • Modify existing equipment to improve product quality, increase part throughput, decrease cost, and/or strengthen safety measures
  • Perform change orders and release processes (ECO's, DCO's, RCO’s) using Agile
  • Manage outside suppliers and contract manufacturers to design and build future automation lines
  • Maintain strict compliance with ISO13485, cGMP, QSR and other applicable Quality Management System standards


Minimum Requirements:

  • Bachelor's or Master's Degree in Mechanical Engineering or related field, or equivalent combination of education and experience to perform at this level
  • 4-6 years of mechanical design experience including, but not limited to, high speed assembly tools, precision mechanism, robotics and automation
  • Hands on experience with electro-mechanical troubleshooting in a high-volume automated manufacturing environment
  • Excellent oral and written communication skills
  • Proven project management skills
  • Strong analytical and problem-solving skills combined with a strong technical presence
  • Proficient in MS Office Suite (MS Word, Excel, PowerPoint, …)
  • Proficient in SolidWorks 2012 or later, PDM or EPDM preferred
  • Proficient with ANSI Y14.5-2009 and use of GD&T

Preferred Requirements:

  • Experience using Agile
  • Experience in the medical device field
  • Experience writing IQ, OQ, and PQ Protocols
  • Conceptual understanding of injection-molded plastic parts