Staff Hardware Engineer

You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies.  You will work with suppliers and automation houses to design and build solutions, deliver technology into high volume manufacturing environments and provide technical support for on-market production. You will bring your expertise and passion for electrical measurement, metrology development and manufacturing test to complex manufacturing automation equipment, working closely in cross-functional teams to integrate cutting-edge technology into our manufacturing processes.  You will ensure high efficiency, precision, and quality in our operations. You will play a pivotal role in ensuring robust new product and new equipment introduction, capacity expansions, and sustained on-market performance. This crucial role supports Dexcom's thrilling growth trajectory in delivering essential, life-changing products to our valued customers. As part of this dynamic and highly effective team, you will collaborate closely across multiple functions, gaining broad exposure to our entire product life cycle.

Where you come in: 

• You will lead and collaborate with internal and external cross-functional teams building, delivering and validating next generation functional test and system test manufacturing processes and equipment

• You will design and conduct feasibility studies, test new and modified designs, analyze integrated electrical, mechanical and fluidics systems into equipment to drive greater yield, performance, and quality

• You will develop test plans, equipment requirements, protocols, and reports to ensure designs meet product specifications, regulatory requirements, and standards for new equipment and processes, including IQ/OQ/PQ protocols

• You will partner with automation integrators to design and build integrated high volume test systems including electrical circuit design, interconnects, environmental controls, temperature management and fluid handling

• You will author and support the execution of equipment acceptance testing (FAT/SAT) and validation protocols (IQ/OQ/PQ) and reports for new or modified production equipment

• You will plan, design, develop, and execute equipment and process improvement projects, ensuring comprehensive documentation and timely communication with leadership and cross-functional teams

• You will lead root cause investigation activities related to equipment and processes leveraging structured problem solving and statistical data analysis to solve problems through root cause understanding

What makes you successful:

• You are proficient designing, implementing and improving manufacturing test equipment & processes, developing test methods and measurement capability to improve product quality, increase productivity, and reduce costs

• You are passionate about connecting product designs to equipment development and manufacturing scale to deliver world class solutions into high volume with industry leading quality

• You are experienced in developing and executing strategies for complex automation, including authoring of protocols and documentation.  You can create efficient plans to accelerate the implementation of new and replicate equipment without compromising quality or compliance

• You are familiar with software development concepts and a system level thinker who can pull all of the disciplines across mechanical, controls, software, metrology and validation together into a cohesive vision for a manufacturing solution

• You partner across manufacturing, engineering and R&D to gather requirements, collaborate on URS development and drive design reviews of all aspects of the development for new automated systems

• You possess exceptional problem-solving and analytical skills, with the ability to interpret complex data and make informed decisions

• You understand the quality and regulatory compliance requirements for product manufacturing automation for high-volume Class II medical devices

• You can work effectively in a team environment, collaborating with cross-functional partners in manufacturing, R&D, supply chain, and quality assurance to achieve common goals

• You effectively communicate with internal teams and external partners. This includes conveying technical concepts clearly, providing timely updates, and fostering collaborative relationships to ensure alignment and successful project outcomes

• You contribute to the innovation in approach, processes, and methodologies while ensuring adherence to company, customer, and industry requirements and specifications. You support the identification and implementation of technology and process solutions to enhance performance and achieve both short-term and long-term objectives

• As an experienced subject matter expert, you mentor and coach team members on best practices, procedures and help build a collaborative culture of winning together

Key Competencies:

• Demonstrated experience in machine automation, manufacturing test/electrical characterization, product test processes, working knowledge of GMP standards and procedures

• Familiarity with PCB design tools, design rules, in circuit test or electrical measurement capability analysis

• Experience working with suppliers, contractors, and machine integrators to drive design, build and delivery of high volume machine automation

• Demonstrated success in driving continuous improvement initiatives using LEAN, KAIZEN, or Six Sigma methodologies to significantly enhance equipment efficiency, reduce operational costs, and elevate product quality standards

• Experience in statistical process control (SPC) and use of software tools such as Minitab or JMP for data analysis, process troubleshooting and optimization

• Eager to take “hands on” approach to system development, system testing, and deployment into a manufacturing environment

• Familiarity with Medical Device industry standards, software development life cycle methodologies, 21 CFR Part 11, cGMP, and GAMP

What you’ll get: 

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community

• A full and comprehensive benefits program

• Growth opportunities on a global scale

• Access to career development through in-house learning programs and/or qualified tuition reimbursement

• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

• 15-25%

Experience and Education Requirements:

• Typically requires a Bachelors degree in a technical discipline with 8-12 years of related industry experience.