Quality Engineer 2

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Summary

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

Essential Duties And Responsibilities

• 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.
• Work closely with Receiving Inspection, Project Quality Engineers, and Supplier Quality Engineers to develop and implement inspection methods, sampling plans, and related procedures.
• 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.
• 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 (i.e. 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.
• Measure task/project percentage completion at critical stages and take appropriate actions as needed to keep tasks/projects on track.
• Plan, manage and prioritize tasks/projects, track progress toward overall goals, and provide periodic updates to management.

Required Qualifications

• Typically requires a Bachelors’ degree in Mechanical Engineering, Manufacturing Engineering, or related field with minimum 2 years of relevant industry experience and/or training.
• Proficiency with inspection equipment such as: CMM (Mitutoyo Vision and Touch Probe System, OGP vision System, digital microscopes, and others).
• 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 is a plus.