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Dexcom Deutschland GmbH · 3 days ago

Staff Process Development Engineer

San Diego, CA

Full-time

Onsite

Senior Level, Lead/Staff

$111K/yr - $185K/yr

5+ years exp

Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). The Staff Process Development Engineer will manage program deliverables related to design and process changes for existing and new medical devices, ensuring high efficiency, precision, and quality in operations.

Medical Device

Responsibilities

You are a global engineering lead, managing execution of program deliverables that focus on both design/process changes to existing on Market product as well as new product development. Deliverables span from proof of concept to pilot manufacturing, to global high volume commercial automation

You will lead process development strategy, design of experiments and measurement system analyses to collect and analyze applicable data relative to program process development targets

You lead design control activities with emphasis on design transfer and a clear 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 provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements

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

Qualification

Process development strategyDesign control activitiesStatistical analysisMedical device design transferTechnical expertise in equipmentCross-functional collaborationContinuous learning cultureAdvanced communicationMentorship experienceTechnical presentations

Required

You have a degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or related field; Master's degree preferred

Your proficiency is a strong technical understanding of experimental study design and measurement system analysis including the appropriate statistical approaches to data analysis

You bring a robust 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 have an advanced communication skillset and can create and deliver concise status reports and presentations from the technical team up through executive leadership

You bring an effective cross-functional collaboration experience amongst peers and leaders

You have mentorship experience that allows you to guide junior engineers, fostering a culture of continuous learning and development within the team

Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience