Staff Process Development Engineer

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:

We are seeking a highly skilled Staff Process Development Engineer with exceptional project leadership capabilities and technical expertise in equipment, test design, statistics, and process development. As a key member of our Engineering team, you will play a pivotal role in leading, developing, and optimizing manufacturing processes for medical devices, ensuring robustness, efficiency, and compliance with regulatory standards.

Where you come in:

• Lead and manage process development projects from concept through commercialization, adhering to timelines and regulatory constraints.

• Design and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvement.

• Gather and analyze data using statistics, Measurement Systems Analysis, and Design Of Experiments efforts and their associated analysis tools

• Utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.

• Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production.

• Provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements.

• Develop and execute test methods and protocols to validate process performance and product quality.

• Plan, design, develop, and execute production cost and/or quality improvement projects including all necessary documentation.

• Develop and provide status presentations from the technical team up through executive leadership

• Mentor and guide junior engineers, fostering a culture of continuous learning and development within the team.

• Develop and execute testing and verification, and documentation activities.

• Follow design, quality, and safety guidelines based on GMP, FDA, and ISO guidelines and related Quality and Safety Standards and Practices.

• Other duties as assigned

What makes you successful:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field; Master’s degree preferred.

• Relevant experience within the medical device industry, with demonstrated proficiency in project leadership.

• Proven expertise in equipment design, test method development, statistical analysis, and process development.

• Experience in at least 1 of the following areas; plastic component assembly, needles, adhesives, epoxies and packaging (sterile barrier, secondary, tertiary).

• Experience with statistics, Measurement Systems Analysis, and Design Of Experiments efforts and their associated analysis tools

• Strong understanding of regulatory requirements (FDA, ISO, etc.) and experience in developing processes compliant with these standards.

• Excellent problem-solving skills and the ability to apply engineering principles to resolve complex technical challenges.

• Effective communicator with the ability to present technical information to diverse audiences and stakeholders.

• Experience with CAD software (e.g., SolidWorks) and statistical analysis software (e.g., JMP, Minitab) is highly desirable.

• Project managem