Senior Process Development Engineer
About The Position
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.
Requirements
- Degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; Master’s degree preferred.
- Proficiency in understanding of experimental study design and measurement system analysis, including the appropriate statistical approaches to data analysis.
- Understanding of medical device design transfer with knowledge of quality and regulatory standards.
- Experience in at least 1 of the following areas; Plastic component assembly, needles, adhesives, epoxies and curing, and packaging (sterile barrier, secondary, tertiary boxing)
- Ability to communicate effectively and generate PowerPoint presentations to deliver objectives and outcomes from the technical team up through executive leadership.
- Cross-functional collaboration experience amongst peers and leaders.
Responsibilities
- 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.
- 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.
- Review design changes and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvements.
- Utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
- Help develop and execute test methods with necessary protocols and reports to validate process performance and product quality.
- 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.
Benefits
- A full and comprehensive benefits program.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
