Sr Process Development Engineer

DexCom • San Diego, CA

2d

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 : Join a dynamic and collaborative multi-disciplined engineering team at Dexcom. We support the organization by standing up pilot manufacturing lines for new product development. These manufacturing lines are intended to prototype, evaluate and validate product designs. This role is crucial to develop the software systems which capture, store and view the data which is produced from the manufacturing line. Where you come in : Design, document and optimize new manufacturing processes for new stations, equipment, and processes within a regulated quality system Utilize process engineering characterization tools including DOE, p-diagrams, risk mitigation (pFMEA), process capability , and six sigma methodologies . Strong root cause analysis skillsets to troubleshoot processes, equipment or product design utilizing tools such as 5-Whys, Fishbone Diagram, Fault Tree Analysis, Is/Is-Not Analysis. Analyze data using statistical tools (JMP or Minitab) to evaluate process/product performance such as DOE, Cp K , hypothesis testing, and optimizing processes with modeling Apply Design for Manufacturing/Assembly (DFM/DFA) principles to optimize product designs for cost, ease of assembly and robust manufacturing processes ensuring scalability. Develop test methods through Measurement System Analysis (MSA) methodology to assess and improve measurement reliability . Includes Test Method Validation (TMV) including protocol development, execution, and reporting. Experience with mentoring junior engineers and foster culture of innovation, accountability and technical excellence. Author and maintain validation documentation including protocols, reports, and risk assessments.

Requirements

• You bring proven experience in medical device or high-tech manufacturing, with a proven track record of launching complex products into high-volume production.
• Excellent knowledge of process characterization and experience with a variety of assembly methods
• You understand the full product lifecycle – from concept to commercialization – and navigate quality systems and frameworks including FDA QSR, ISO 13485, ISO 14971 and EU MDR
• Listen and consider a variety of perspectives from cross-functional teams, including R&D, Quality, Operations and Regulatory to meet project goals.
• You communicate with clarity and executive presence, translating technical insights into actionable strategies for diverse stakeholders.
• Experience with project management tools such as JIRA, Confluence, Smartsheet
• 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

Responsibilities

• Design, document and optimize new manufacturing processes for new stations, equipment, and processes within a regulated quality system
• Utilize process engineering characterization tools including DOE, p-diagrams, risk mitigation (pFMEA), process capability , and six sigma methodologies
• Strong root cause analysis skillsets to troubleshoot processes, equipment or product design utilizing tools such as 5-Whys, Fishbone Diagram, Fault Tree Analysis, Is/Is-Not Analysis.
• Analyze data using statistical tools (JMP or Minitab) to evaluate process/product performance such as DOE, Cp K , hypothesis testing, and optimizing processes with modeling
• Apply Design for Manufacturing/Assembly (DFM/DFA) principles to optimize product designs for cost, ease of assembly and robust manufacturing processes ensuring scalability.
• Develop test methods through Measurement System Analysis (MSA) methodology to assess and improve measurement reliability . Includes Test Method Validation (TMV) including protocol development, execution, and reporting.
• Experience with mentoring junior engineers and foster culture of innovation, accountability and technical excellence.
• Author and maintain validation documentation including protocols, reports, and risk assessments.

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community
• A full and c omprehensive benefit s progra m
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursemen t.
• 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