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Technical Operations Engineer

QualStaff Resources

Technical Operations Engineer

San Diego, CA
Full Time
Paid
  • Responsibilities

    Job Description

     

     

     

    SUMMARY: 

    This position will provide technical support for the Operations Team by systematic troubleshooting, investigation, process improvement and product improvement. The Technical Operations Engineer will be involved in product and process sustaining activities for the manufacture of point-of-care, in-vitro diagnostic instruments and test cassettes. This position requires relevant experience and experience working under FDA QSR/ISO 13485 environment.

     

    RESPONSIBILITIES:

    • Assist in the evaluation of the manufacturing processes by designing and conducting tests; applying knowledge of product design, fabrication, assembly, tooling, and materials; soliciting observations from operators
    • Assure product and process quality by designing testing methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes
    • Investigate non-conformances and customer issues related to instrumentation and present risk assessments and resolutions
    • Collaborate with the engineering team for identifying the most effective production process 
    • Keep equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service
    • Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors
    • Assist in Improving manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout
    • Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements
    • Prepare product and process reports by collecting, analyzing, and summarizing data and trends
    • Be assigned with various tasks that need to be completed along with the Engineering projects
    • Implementation and integration of automation systems
    • Assist in production scale-up from manual to semi-automated and fully automated solutions
    • Design verification and validation per ISO 13485

     

    KNOWLEDGE AND SKILL: 

    • At least 2 years of experience in the development and/or manufacture of IVD/Medical devices
    • Experience with programmable logic controllers
    • Hands on experience in: CAD/CAM design, SolidWorks 
    • Experience with machine vision systems
    • Experience in the integration of automated production systems
    • Prior experience working under FDA QSR / ISO 13485 regulated environment
    • Experience with 6 sigma, lean manufacturing, and 5S a plus
    • Proficient at Manufacturing Methods and Procedures
    • Able to present technical information in an understandable format 
    • Ability to work in a multidisciplinary team environment, to multi-task, to handle frequently changing job functions and to rapidly learn new techniques and approaches
    • Must have good communication skills and work well in a fast-paced, start-up environment
    • Ability to resolve issues quickly and recommend preventive solutions
    • Strong knowledge of statistical analysis, DOE, MS Office Suite
    • Strong GMP and GDP knowledge

     

    EDUCATION/EXPERIENCE REQUIRED: 

    • BS in Mechanical Engineering or other relevant Engineering discipline
    • 2-5 years’ experience working in FDA and ISO 13485 regulated company
    • Previous Manufacturing Engineering experience and cGMP and/or CLIA laboratory experience
    • Previous experience in biotech / IVD / Medical Device
    • Experience with medical device manufacturing processes qualification (IQ/OQ/PQ)
    • Product manufacturing, inspection, and testing experience 
    • High level problem solving, and reasoning skills
    • Experience in production support and/or process development