Senior Hardware Systems Engineer – CM & Traceability

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:

Join a passionate team of engineers who are truly making a difference in the lives of people with diabetes! As the Senior Hardware Systems Engineer – CM & Traceability (Wearables), you will play a critical role in ensuring the integrity, reliability, and controlled configuration of our wearable CGM systems (sensors, applicators, and BLE firmware) from design through manufacturing. We're a collaborative Systems Engineering team that drives process improvement, maintains regulatory compliance, and guarantees that our products meet the highest quality standards. If you are driven, detail-oriented, and passionate about contributing to high-quality CGM solutions, this is the team for you.

Where you come in:

• You will design, implement, and maintain a comprehensive system compatibility matrix that clearly outlines compatible hardware and software versions across all Dexcom CGM products, with a primary focus on our wearable sensors, applicators, and BLE firmware.

• You will create and maintain accurate product configuration documentation, including BOMs, ECOs, reflecting the current product status for our hardware wearable components.

• You will lead configuration change control processes, evaluating, approving, and documenting all proposed configuration changes for hardware and firmware, and leading meetings.

• You will proactively collaborate with Systems Engineers, Operations, Quality, Regulatory, and design teams to analyze existing product documentation (e.g., G7, Stelo) and identify gaps in requirements traceability to manufacturing process controls specifically for our wearable sensors, applicators, and BLE firmware.

• You will develop and maintain comprehensive traceability matrices, linking design inputs, design outputs, and manufacturing processes for hardware wearable components.

• You will define and document manufacturing requirements based on design requirements, specifications, and performance criteria.

• You will actively participate in design reviews, providing valuable input on manufacturability and testability of our hardware wearable products.

• You will ensure all product configurations adhere to FDA regulations, ISO 9001, ISO 13485, and other applicable standards.

What makes you successful:

• Your expertise include proficiency in using Jama Connect, Jira, Lucid, Confluence and other tools.

• You possess a deep understanding and practical application of configuration management principles and best practices within a complex product development environment, specifically related to hardware wearables.

• You have proven experience tracing high-level design input requirements to manufacturing process controls.

• You have experience working within the medical device industry or other regulated sectors with a solid grasp of FDA regulations and ISO standards.

• You have expertise in requirements elicitation, analysis, and management, ideally applying INCOSE Requirements standards.

• You have a strong understanding of product development lifecycle, from concept to manufacturing.

• You have demonstrated understanding of systems engineering principles in HW and SW, including requirements management, system architecture, and verification planning.

• You possess exceptional communication and collaboration skills to effectively interact with