Senior Diagnostic Consumables Engineer

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

As a Senior Diagnostic Consumables Engineer you will be a part of a fast pace, multi-disciplines, and creative team that drive new product development and implement continuous improvements to new and existing processes. The ability to develop products, trouble-shoot, define root cause, provide resolution, and implement the necessary changes efficiently in an FDA regulated environment is critical. Past related experience is desired, but the ability to identify problem and create a solution through research and solid technical principles / disciplines is necessary.

 

  • Create and develop new invasive and noninvasive medical device product(s) from initial design to market and manufacturing release.
  • Investigate and evaluate existing technology.
  • Design and implement new methodologies, materials, machines, and/or processes.
  • Conduct feasibility studies of the design to determine ability to function as intended.
  • Coordinate and drive new and existing consumable part and process qualifications from inception through completion in accordance with FDA and ISO guidelines.
  • Maintain detailed documentation throughout all phases of research and development through manufacturing .
  • Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
  • Develop and document business practices, processes, procedures, and work instructions
  • Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables.
  • Perform failure analysis on Cepheid custom injection molded parts.
  • Consult with engineers and other staff members to resolve issues related to product fabrication, product quality improvement, product assembly and automation, cost controls and reduction.
  • Consult with engineers and other staff members to evaluate and improve the interface between consumables, manufacturing processes, and diagnostic platform.
  • Provide training and direction to junior members of your team.
Requirements
  • Bachelors Degree in Mechanical Engineering and/or equivalent combination of education and experience to perform at this level
  • A minimum of 8 years direct experience in engineering
  • Strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems
  • Experience with failure investigations, root cause failure analysis, process engineering, etc.
  • Proficiency with Solid Works
  • Proficiency with drafting standards ANSI/ASME, and GD&T
  • Proficiency with IQ, OQ, PQ, FDA, ISO9001
  • Demonstrated ability to understand and comply with applicable FDA regulations and company operating procedures, processes and policies
  • Fluent in the use of MS Excel for data analysis and presentation in graphic formats
  • Solid mathematical skills with basic statistics knowledge
  • Working knowledge of design of experiments and interpretation of test results
  • Excellent communication skills. Must be able to communicate verbally in an efficient and effective manner and be proficient in document preparation and editing, including detailed test planning and report writing. Must be able to reduce data to coherent form for clear presentation.
  • Must have ability to meet deadlines on multiple concurrent projects
  • Must have demonstrated ability to communicate and coordinate efficiently across multiple functions and employee levels
  • Self-directed requiring minimum supervision

 

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