Sr Process Development Engineer

Dexcom • San Diego, CA

5d

About The Position

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: The Global Engineering team works in new product introduction as the bridge between R&D and operations. The Sensor Process Development team specifically focuses on designing and qualifying new processes from initial pilot and clinical builds to product launch and supporting through scale-up stabilization. This includes manufacturing process automation, test method development, specification development, and product stability testing throughout various stresses seen in commercial production and use. This team works very closely with R&D on the latest and novel technologies and concepts for glucose sensing subsystems. We are looking for someone with a thorough understanding of medical device development and a practical problem solver to join a fast-paced and supportive environment! Where you come in: You will lead process development/scale up and characterization, test method development, and integration of new products and processes from R&D, focused on the sensor performance space in test method development, sterilization, and product monitoring You will drive an understanding of system level trade-offs and interactions of biosensor physiology with underlying scientific challenges of sterilization, transit, and root cause understanding of product failure modes You will optimize analytical methods for quantifying the effects of stresses in commercial product use on sensor performance including aging, sterilization, storage/shipping excursions, wear, etc. You will solve problems where the path forward is ambiguous and cross-functional You will thrive on a diverse cross-functional team and across sites to implement global engineering solutions You will partner with development and sustaining operations teams in the US and abroad to align commercial feasibility and collaborate on implementation plans as technologies mature

Requirements

• You have a strong background in risk management, root cause analysis, experimental design, and the ability to use statistical analysis to make data-backed conclusions
• You can independently manage projects, timelines, and influence project teams to deliver useful and scalable solutions
• You have a demonstrated ability to qualify and validate equipment and test methods, and preferably training in Lean Six Sigma or other advanced practical statistical applications
• You are highly organized and detail-oriented with a strong analytical and broad engineering mindset. You understand how to troubleshoot analytical processes in the medical device or pharmaceutical field, and can quickly design experiments or test plans to scope problems and find solutions
• You are proficient in technical writing, verbal and visual communication, and demonstrated ability to coordinate and prioritize work to close-out project objectives on time
• You have a Bachelor’s degree, or preferably higher degree, in Bioengineering, Biomedical Engineering, Chemical Engineering, Materials Science and Engineering, Chemistry, or related field with experience in the biotech, pharmaceutical, or medical device industry

Responsibilities

• You will lead process development/scale up and characterization, test method development, and integration of new products and processes from R&D, focused on the sensor performance space in test method development, sterilization, and product monitoring
• You will drive an understanding of system level trade-offs and interactions of biosensor physiology with underlying scientific challenges of sterilization, transit, and root cause understanding of product failure modes
• You will optimize analytical methods for quantifying the effects of stresses in commercial product use on sensor performance including aging, sterilization, storage/shipping excursions, wear, etc.
• You will solve problems where the path forward is ambiguous and cross-functional
• You will thrive on a diverse cross-functional team and across sites to implement global engineering solutions
• You will partner with development and sustaining operations teams in the US and abroad to align commercial feasibility and collaborate on implementation plans as technologies mature

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees