QA Engineer 2

Dexcom; George Town; On-site; MYR 89,000 - 134,000; Full time

Job summary

Dexcom is seeking a Quality Engineering professional to liaison with Receiving Inspection, R&D and Supplier Quality to ensure timely communication of project deliverables, including specifications, drawings, fixtures, and sampling plans.

The role emphasizes development of measurement systems, fixture design, and process validation within an R&D and GMP manufacturing environment.

Qualifications

• Bachelor's degree in Mechanical, Manufacturing Engineering or related field with 2+ years of experience.
• Experience with CMM inspection equipment including Mitutoyo Vision/Touch Probe, OGP vision systems, and digital microscopes.
• Experience with CAD tools (SolidWorks preferred) and statistical analysis software (Minitab).
• Proficiency with Microsoft Office products.
• Experience with basic statistical analysis including Gage R&R and method validations.
• Experience in inspection equipment and fixture design, development, and implementation.
• Previous involvement in medical device or regulated industries.
• Ability to manage self-directed projects in R&D and GMP environments.
• Strong interpersonal, written, and verbal communication; teamwork oriented.

Responsibilities

• Provide direct support to Receiving Inspection evaluating inspection methods, sampling plans, and fixture inspections.
• Collaborate with Receiving Inspection, Project Quality, and Supplier Quality to develop methods and procedures.
• Input to design and development of fixtures for measuring components in Receiving Inspection.
• Attend design control and phase exit meetings.
• Create CMM programs to measure complex molded parts and assemblies.
• Develop inspection processes for high-volume components.
• Conduct Gage R&R and measurement system analyses.
• Define measurement strategies and validate methods and equipment.
• Support design and fabrication of fixtures, tooling, and measurement equipment.
• Track task progress and keep management updated on milestones.

Skills

Statistical analysis

Fixture design

GD&T

Project management

Communication skills

Teamwork

Adaptability

Education

Bachelor's degree in Mechanical/Manufacturing Engineering or related field

Tools

SolidWorks

Minitab

Mitutoyo Vision / Touch Probe

OGP Vision System

Microsoft Office

Job description

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 & 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 takes appropriate actions as needed to keep tasks/projects on track
• 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 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 other)
• 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

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

AI in Hiring Notice

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].