Senior Receiving Inspection Quality Engineer

Dexcom   •  

San Diego, CA

5 - 7 years

Posted 298 days ago

This job is no longer available.

As a member of the Quality Engineering team, this engineer will liaison closely with R&D, Supplier Quality, Operations Engineering, and Receiving Inspection to ensure open and timely communication of pipeline project deliverables including but not limited to material specifications, drawings, fixture requirements, Gage Repeatability & Reproducibility Studies, First Article Inspections, inspection procedures, inspection methods, and sampling plans.

 

Essential Duties and Responsibilities:

  • Provide the primary input to the design, development and implementation of fixtures for measuring component parts in Receiving Inspection.
  • Attend assigned design control and phase exit meetings on behalf of Quality Engineering.
  • Work closely with Receiving Inspection, Project Quality Engineers, and Supplier Quality Engineers to develop and implement inspection methods, sampling plans, and related procedures.
  • Provide direct and ongoing support to Receiving Inspection in evaluating inspection methods, process improvements, sampling plans, coordination of first article component and fixture inspections, selection and qualification of inspection equipment.
  • Create vision system CMM programs to semi-automatically measure complex molded component parts and sub-assemblies
  • Develop inspection processes for complex and high volume component throughput
  • Create and conduct measurement capability assessments (eg Gage Repeatability and Reproducibility)
  • Design and develop methods to determine measurement accuracy and precision through testing and analysis
  • Evaluate and determine cause for measurement variation
  • Create test strategies and conduct process/equipment/measurement method qualifications and validations
  • Provide key support in the design and fabrication of mechanical fixtures, tooling, and equipment for component/sub-assembly measurement
  • Work closely with Supplier Development, Research & Development, Quality and other support groups and departments
  • Measure task/project percentage completion at critical stages and takes appropriate actions as needed to keep tasks/projects on track
  • Independently plan, manage and prioritizes tasks/projects, tracks progress toward overall goals, and provides periodic updates to management

 

 

Required Qualifications:

  • Typically requires a Bachelors’ degree in Mechanical Engineering, Manufacturing Engineering,   or related field with 5+ years of relevant industry experience and/or training.
  • Proven ability to work hands-on in a fast-paced environment
  • Proficiency with inspection equipment such as: CMM (Mitutoyo Vision and Touch Probe System, OGP vision System, digital microscopes, and other), is desired.
  • Proficiency with engineering software tools for CAD (SolidWorks preferred), engineering analysis, and statistical analysis (e.g. Minitab)
  • Proficiency with Microsoft Office Products
  • Proficiency with basic statistical analysis (normality, standard deviation, variance, and comparison of data groups) including Gage R&R and test method validations.
  • Proficiency in inspection equipment and fixture design, development and implementation
  • Previous direct involvement in medical device industry or a regulated industry
  • Ability to run self-directed projects, maintain timelines, transfer technology and execute projects in an R&D and GMP manufacturing environment
  • Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
  • Strong interpersonal and teamwork skills
  • Demonstrated written and verbal communication skills
  • Proficient with geometric dimensioning and tolerancing and the ability to read mechanical drawings. 
  • Certified Quality Engineer and LeanSix SigmaBlack Belt certifications are a plus

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