Mechanical Engineer

Sunnyvale, CA

Post Date: 02/26/2018 Job ID: RMA 5200 Position Categories: Engineering Pay Rate: Depending on experience

A biotech manufacturing company in Sunnyvale, CA is looking for a Mechanical Engineer to be responsible for the design, development, 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. 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.

Responsibilities:

  • 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

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

Experience in the medical device field preferred

Experience writing IQ, OQ, and PQ Protocols a plus

Conceptual understanding of injection-molded plastic parts preferred

Experience using Agile a plus

For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.

Richmar is an Equal Opportunity Employer.


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