Senior Biomedical Engineer

In this role, you will develop and execute data-driven experimental strategies to characterize component- and system-level performance and translate technical insights into actionable improvements that influence the design and reliability of next-generation Continuous Glucose Monitoring (CGM) sensors. The role emphasizes structured problem-solving methodologies, including DMAIC, to drive product robustness, performance, and continuous improvement.

Responsibilities

• Troubleshoot and characterize performance anomalies in microfabricated electrochemical biosensors through systematic experimentation, advanced analytical techniques, and data-driven analysis.
• Develop, record, and perform various root-cause investigations on systems and components to determine failure mechanisms.
• Write formal analysis reports, resulting in clear and accurate messaging about analysis findings to both the submitter and a broader audience.
• Use working knowledge of failure modes of products 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 for improvements in product quality, reliability, manufacturability, and functionality.
• Initiate and lead the efforts on implementing improvements identified as a part of continuous improvement.
• Obtain, interpret, and utilize data from formal test, complaint handling, and other document repositories.
• Develop new test methodologies to aid in the failure analysis of components and products.
• Identify and research component & system failures in the early stages of product development to improve product quality and reliability.
• Development of analytical methodologies and equipment acquisitions to ensure strategic failure analysis capabilities for future technologies and products.
• Contribute to development of continuous glucose monitoring subsystems as relevant to the group goals.
• Design, develop and provide safety testing, repair, and maintenance of biomedical equipment; ensure compliance 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 activities such as compound screening and compound optimization programs, and developing and running enzyme assays.

Required Knowledge and Experience

Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Preferred Qualifications

• Advanced degree in biomedical engineering, chemical engineering or related engineering field with at least 5 years of experience in Medical Device industry, or an advanced degree with at least 3 years of experience in Medical Device industry.
• Demonstrated experience developing electrochemical medical devices within design controls and Quality Management systems; familiarity with FSA requirements, ISO 13485, risk analysis and FMEA.
• Demonstrated experience in 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 (T-test, ANOVA and significance testing at a minimum).
• Knowledge about in-vitro and in-vivo testing of subcutaneous medical devices.
• Certification in DMAIC or equivalent Scientific Method problem solving for root cause analysis.
• Experience with statistical analysis of data (Ex. Minitab, JMP, Matlab, etc.).
• Capable of working on multiple projects in a deadline driven environment.
• Greenbelt in DRM, Six Sigma.
• Cleanroom procedural experience.