Senior Process Development Engineer

1 DexCom Inc

California

On-site

USD 91,000 - 152,000

Full time

3 days ago
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Benefits offered by this job

Comprehensive benefits
Career development programs
Tuition reimbursement
Global opportunities

Job summary

Dexcom is seeking an experienced engineer to join Global Engineering in Operations, focusing on end-to-end oversight of manufacturing automation. You will drive design transfer, qualification, validation, and change management for medical devices, ensuring scalability, efficiency, and quality across sites.

You will collaborate with R&D, QA, Regulatory, and Supply Chain to enable robust product development and transfer of deliverables within the quality management system.

Qualifications

  • Bachelor-level technical degree with advanced design and development exposure.
  • Strong experience in design transfer and regulatory awareness.
  • Proven ability to analyze process data and drive improvements.

Responsibilities

  • Lead design transfer activities and optimize manufacturing processes.
  • Develop experiments and measurement analyses to validate processes.
  • Collaborate with R&D, QA, Regulatory, and supply chain functions.
  • Use statistics to drive process capability and quality improvements.

Skills

Statistical analysis
Design transfer
Cross-functional collaboration
PowerPoint proficiency
Experimental design

Education

Bachelor's degree in Mechanical, Biomedical, or Chemical Engineering
Master's degree preferred
PhD optional or not required

Job description

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: 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 manufacturers, 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.

Where you come in:

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.

What makes you successful:
  • 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
    • 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.
What you’ll get:
  • 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.
Experience and Education Requirements:

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.

Travel Required: 5-15%

Salary: $91,400.00 - $152,300.00

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.

Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

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