Staff Process Development Engineer

3 days ago

San Diego, California, United States Dexcom Full time
About Dexcom

Dexcom is a pioneer and global leader in continuous glucose monitoring (CGM). Our mission is to empower people to take control of their health by providing personalized, actionable insights that drive better health outcomes.

Job Summary

We are seeking a highly skilled Staff Process Development Engineer to join our Engineering team. As a key member of our team, you will play a pivotal role in leading, developing, and optimizing manufacturing processes for medical devices, ensuring robustness, efficiency, and compliance with regulatory standards.

Key Responsibilities
  • Lead and manage process development projects from concept through commercialization, adhering to timelines and regulatory constraints.
  • Design and optimize manufacturing processes for new and existing medical devices, focusing on scalability, efficiency, and quality improvement.
  • Gather and analyze data using statistics, Measurement Systems Analysis, and Design Of Experiments efforts and their associated analysis tools.
  • Utilize statistical tools and methods to analyze process data, conduct capability studies, and implement process controls.
  • Collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure seamless roll out of processes into production.
  • Provide technical expertise in equipment selection, qualification, and validation, ensuring equipment meets performance and regulatory requirements.
  • Develop and execute test methods and protocols to validate process performance and product quality.
  • Plan, design, develop, and execute production cost and/or quality improvement projects including all necessary documentation.
  • Mentor and guide junior engineers, fostering a culture of continuous learning and development within the team.
  • Develop and execute testing and verification, and documentation activities.
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field; Master's degree preferred.
  • Relevant experience within the medical device industry, with demonstrated proficiency in project leadership.
  • Proven expertise in equipment design, test method development, statistical analysis, and process development.
  • Experience in at least 1 of the following areas; plastic component assembly, needles, adhesives, epoxies and packaging (sterile barrier, secondary, tertiary).
  • Experience with statistics, Measurement Systems Analysis, and Design Of Experiments efforts and their associated analysis tools.
  • Strong understanding of regulatory requirements (FDA, ISO, etc.) and experience in developing processes compliant with these standards.
  • Excellent problem-solving skills and the ability to apply engineering principles to resolve complex technical challenges.
  • Effective communicator with the ability to present technical information to diverse audiences and stakeholders.
  • Experience with CAD software (e.g., SolidWorks) and statistical analysis software (e.g., JMP, Minitab) is highly desirable.
  • Project management certification (PMP) or Six Sigma certification (e.g., Black Belt) is a plus.
  • Experience with Databases and queries for data collection, aggregation, and analysis.
What We Offer
  • A front row seat to life changing CGM technology.
  • 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.
Travel and Work Environment

This role requires 25-50% travel. Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs. You must live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).

Dexcom is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive environment where all employees feel valued and respected.

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