Principal Biomedical Engineer

About the role

We are seeking a Principal Biomedical Engineer to join our Continuous Glucose Monitoring Sensor R&D team. This individual will lead the design and development of next-generation CGM sensors, focusing on sensor performance, reliability, and manufacturability.

Responsibilities

• Leads key elements of the design transfer activities, including defining and refining statistically robust in-process check specifications, statistically justified sample size determination, and rejection criteria.
• Leads advanced statistical analysis and data-driven investigations to support sensor process optimization, performance modeling, and manufacturing decision-making.
• Applies first-principles understanding of glucose sensor behavior, including electrochemistry, enzyme-mediated sensing, mass transport, membrane design, tissue interface, interferents, drift, and stability.
• Applies data analysis and statistical methodologies to generate insights on sensor performance, drive experiment design and project next steps.
• Utilizes technical skills associated with Six Sigma, Lean, DRM/DFSS and other appropriate continuous improvement techniques.
• Mentors scientists and engineers to promote rigorous experimental design, and strengthens first-principles technical decision making across Sensor R&D.
• Ensures work is performed in compliance with applicable quality system requirements, design controls, medical device standards, and regulatory expectations.

Requirements

• Bachelor’s degree with 7+ years of relevant experience; or advanced degree with 5+ years of relevant experience.
• Experience in glucose sensor, biosensor, electrochemical sensor, wearable sensor, or related medical device sensor development.
• Demonstrated hands-on experience in sensor design, first-principles problem solving, structured experimentation, and data-driven decision making.
• Expertise in advanced statistical methods: DOE, ANOVA, mixed-effects models, hypothesis testing, SPC, process capability, MSA/Gauge R&R, and sample size/power analysis.
• Familiarity with analytical method transfer and equipment/process validation in cGMP environments.
• Working knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP documentation standards as they apply to data analysis and validation reports.
• Proven ability to influence technical and business decisions across cross-functional teams.
• Excellent written and verbal communication skills, including the ability to clearly communicate complex analytical topics to senior leaders and technical teams.

Preferred Qualifications

• Experience in Python programming (Pandas, NumPy, SciPy), SQL, and familiarity with JMP or Minitab.
• Knowledge of ML libraries (scikit-learn, PyTorch, OpenCV).

Qualifications

• Physical Job Requirements: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

Benefits & Compensation

At MiniMed, we offer a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance, a Health Savings Account, a Healthcare Flexible Spending Account, life insurance, long-term disability leave, a dependent daycare spending account, and a 401(k) plan with company match. We also provide short-term disability coverage, paid time off and holidays, participation in our Employee Stock Purchase Plan, and access to our Employee Assistance Program. Eligible employees may also benefit from our Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.