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MiniMed

Develops automated insulin delivery systems

Senior Biomedical Engineer

Biomedical Engineering & Medical DevicesPosted on Nov 9
Full-timeNorthridge, Los Angeles, CA, USAIn-person

About the Job

Requirements

  • Requires a bachelor's degree and a minimum of four years of relevant experience, or an advanced degree with a minimum of two years of relevant experience.
  • Demonstrated experience developing electrochemical medical devices within design controls and Quality Management Systems; familiarity with FSA requirements, ISO 13485, risk analysis, and Failure Mode and Effects Analysis.
  • Demonstrated experience solving complex failure analysis investigations using structured problem-solving methodologies such as DMAIC, root cause analysis, fault-tree analysis, and hypothesis-driven experimentation.
  • Direct experience in characterization, design of experiments, and data analysis methodologies, including T-tests, ANOVA, and significance testing.
  • Knowledge of in-vitro and in-vivo testing of subcutaneous medical devices.
  • Capable of working on multiple projects in a deadline-driven environment.
  • Experience with cleanroom procedures.

Responsibilities

  • Troubleshoot and characterize performance anomalies in microfabricated electrochemical biosensors through systematic experimentation, advanced analytical techniques, and data-driven analysis.
  • Develop, record, and perform root-cause investigations on systems and components to determine failure mechanisms.
  • Write formal analysis reports that clearly and accurately communicate findings to the submitter and a broader audience.
  • Use working knowledge of product failure modes to work with technicians and other R&D engineers to assess existing and potential failures.
  • Work with R&D and quality engineers to identify opportunities to improve product quality, reliability, manufacturability, and functionality.
  • Initiate and lead efforts to implement improvements identified through continuous improvement activities.
  • Obtain, interpret, and use data from formal testing, complaint handling, and other document repositories.
  • Develop new test methodologies to aid in failure analysis of components and products.
  • Identify and research component and system failures in the early stages of product development to improve product quality and reliability.
  • Develop analytical methodologies and acquire equipment to ensure strategic failure analysis capabilities for future technologies and products.
  • Contribute to development of continuous glucose monitoring subsystems in support of group goals.
  • Design, develop, and provide safety testing, repair, and maintenance of biomedical equipment.
  • Ensure biomedical equipment complies with applicable regulatory requirements and quality control standards.
  • Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes.
  • Participate in compound screening and compound optimization programs, and develop and run enzyme assays.

Desired Qualifications

  • An advanced degree in biomedical engineering, chemical engineering, or a related engineering field, with at least five years of experience in the medical device industry, or an advanced degree with at least three years of experience in the medical device industry.
  • Certification in DMAIC or equivalent scientific-method problem solving for root-cause analysis.
  • Experience with statistical analysis software such as Minitab, JMP, or MATLAB.
  • Green Belt in DRM or Six Sigma.

About the Company

MiniMed

Develops automated insulin delivery systems

MiniMed develops insulin delivery and automated insulin delivery systems, plus related sensors, pens, and software. Its products couple glucose sensors with pumps or smart pens to automatically adjust insulin or simplify dosing. It differentiates itself with an integrated ecosystem of devices and software and a large share of recurring revenue from sensors, consumables, software and services across more than 80 countries. Its goal is to be a leading global provider of insulin delivery and glucose monitoring solutions that help people with diabetes achieve better glycemic control.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Los Angeles, CA
Founded
1983

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