Senior Process Development Engineer

Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes - while empowering our community to take control of diabetes.

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, automation houses, and internal manufacturing. Including providing technical support for on-market production at our manufacturing sites. You will bring your expertise and passion for the development, qualification, validation and change management of 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 Operations. You will play a pivotal role in ensuring robust new product development, capacity expansion, 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.

• You will participate in new product process development, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets.
• You execute design control activities with emphasis on design transfer and an understanding of system design and the linkage between technical and business requirements, design and process failure modes and process controls.
• You will review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements.
• You will utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
• You will help develop and execute test methods with necessary protocols and reports to validate process performance and product quality.
• You will collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing to ensure seamless business strategy and transfer of technical deliverables in the quality management system.

• You have a degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field;
  Master’s degree preferred.
• Your proficiency is an understanding of experimental study design and measurement system analysis, including the appropriate statistical approaches to data analysis.
• You bring an understanding of medical device design transfer with knowledge of quality and regulatory standards.
• You have experience in at least 1 of the following areas;
  Plastic component assembly, needles, adhesives, epoxies and curing, and packaging (sterile barrier, secondary, tertiary boxing)
• You are able to communicate effectively and generate PowerPoint presentations to deliver objectives and outcomes from the technical team up through executive leadership.
• You bring cross-functional collaboration experience amongst peers and leaders.

• 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.

5-15%

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.

Please note:

The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and…