Sr. Mechanical Engineer - Automation Validation

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.

Meet the team:

You will be part of the Global Engineering team within Operations, tasked with end-to-end technical oversight of our manufacturing technologies spanning our suppliers, contract manufactures and automation houses.  Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for plastic injection molding automation and validation, 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 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 collaborate with internal and external cross-functional teams supporting the validation strategy development and implementation for product assembly equipment, system architecture, robotics concepts, and tooling.

• 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 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 at contract manufacturing partners. Assist in protocol execution as needed.

• You will support the change management assessment and any validation requirements for on-market equipment improvement or other change management projects, ensuring comprehensive documentation and timely communication, and assure quality and regulatory compliance is maintained.

• You will support feasibility studies, testing new and modified designs, and analyze mechanical systems and equipment to drive greater yield, performance, and quality.  

What makes you successful:

• You are experienced in developing and executing validation strategies for complex automation, including authoring of documentation and date review.  You can create efficient strategies to drive speed to implementation for new and replicate equipment without compromising quality or compliance.  

• You collaborate for URS development & design reviews of all control aspects of the development of an automated system.

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

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

• 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.

Key Competencies:

• Expertise in regulatory requirements and standards such as FDA 21 CFR Part 11, and ISO standards. This includes the ability to develop and execute validation protocols (IQ/OQ/PQ) to ensure compliance.

• Bachelor’s degree in mechanical engineering or related field. 

• Possesses hands-on experience with high volume automation assembly machines from development to qualification through to on-market continuous improvement and change management.  

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

• Proficiency in SolidWorks, dimensional tolerancing and GD&T Standards.

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

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 Bachelor's degree in a technical discipline, and a minimum of 5 - 8 years related experience or Master's degree and 2 - 5 years equivalent industry experience or a PhD and 0 - 2 years experience.

Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.

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.