Principal Biomedical Engineer

About the role

We anticipate the application window for this opening will close on 13 Jul 2026. At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

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.
• Applies analytical tools, including statistical learning methods where appropriate, to support defect detection, classification, and sensor process monitoring improvements.
• 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.
• Safeguards work 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 with working knowledge of how sensor design parameters (e.g., electrode geometry, enzyme loading, membrane stacks) affect sensor performance, reliability, and manufacturing feasibility.
• Demonstrated hands-on experience in sensor design, first-principles problem solving, structured experimentation, and data-driven decision making.
• Demonstrated expertise in advanced statistical methods: DOE, ANOVA, mixed-effects models, hypothesis testing, SPC, process capability, MSA/Gauge R&R, and sample size/power analysis.
• Experience with pFMEA, control plans, and sampling plan design in a high-volume manufacturing context.
• 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.
• Familiarity with or hands-on experience in image-based analytics or computer vision methods as applied to manufacturing inspection or sensor characterization.
• Python proficiency (Pandas, NumPy, SciPy) and SQL; familiarity with JMP or Minitab strongly preferred; knowledge of ML libraries (scikit-learn, PyTorch, OpenCV).
• 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package. For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $153,000.00 - $261,000.00 USD. Actual compensation may vary based on factors including experience, education, certifications, skills, market conditions, internal equity, and geographic location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

About MiniMed

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for real life, predictive insights that stay a step ahead, and always on support when it’s needed most. At the heart of everything we do is a simple Mission: to make every day a better day for people with diabetes.