Principal Biomedical Engineer

Job Description

Lead technical investigations into CGM sensor performance and failures, using structured problem-solving and data-driven experiments to identify root causes and drive product improvements. Collaborate across design, manufacturing, quality, and regulatory teams to develop test methods, assess reliability, document findings, and support verification, validation, and CAPA activities.

Requirements: Requires a bachelor's degree in biomedical engineering, chemical engineering, or a related engineering field with at least seven years of medical-device experience, or an advanced degree with at least five years. Candidates must have experience developing electrochemical medical devices under design controls and quality management systems, leading complex failure investigations, and applying structured problem-solving methods such as DMAIC, root cause analysis, and fault-tree analysis.

Key Skills: Electrochemical Sensor Development, Medical Device Product Development, Failure Analysis, Root Cause Analysis, DMAIC, Design Controls, Quality Management Systems, FMEA, Risk Analysis, Hypothesis-Driven Experimentation, Design of Experiments, Statistical Analysis, Cross-Functional Leadership, Verification and Validation, CAPA

Benefits: Health Insurance, Dental Insurance, Vision Insurance, Health Savings Account, Healthcare Flexible Spending Account, Life Insurance, Long-Term Disability Coverage, Dependent Daycare Spending Account, Incentive Plans, 401(k) With Company Match, Short-Term Disability Coverage, Paid Time Off, Paid Holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-Qualified Retirement Plan Supplement, Capital Accumulation Plan