Principal Biomedical Engineer

Principal Biomedical Engineer

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.

About the Role

As a member of the Minimed's – Continuous Glucose Monitoring Sensor R&D team the Principal Biomedical Engineer will be responsible for providing technical and scientific leadership for the design and development of next-generation continuous glucose monitoring (CGM) sensors. This individual in this role will have deep understanding of how wearable electrochemical sensors function, including how the electrode geometry, enzyme loading, membrane stacks and tissue interface govern sensor performance, manufacturability, and reliability. This foundational sensor knowledge is critical in ensuring that statistical model development and analytical frameworks reflect true sensor physics. The individual in this role will own and lead key elements of design transfer into manufacturing, including applying statistically robust methods for defining and refining in-process check specifications, statistically justified sample size determination, and substrate rejection criteria. As part of continuous improvement activities, the individual in this role will apply machine learning tools to improve upon current process monitoring technologies. The work will focus on technologies and methods that enable improved sensor design and manufacturability. This Principal Biomedical Engineer will partner cross functionally to highlight insights from real-world sensor performance data, driving continuous sensor improvement initiatives and directly informing next-generation sensing platform designs. This role is intended for a recognized technical leader who can mentor strong teams, influence senior decisions, and help strengthen MiniMed's culture of innovation, analytical rigor, and patient impact.

Responsibilities may include the following and other duties may be assigned.

• 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.
• Ensures work is performed in compliance with applicable quality system requirements, design controls, medical device standards, and regulatory expectations.

Required Knowledge and Experience:

Bachelor's degree with 7+ years of relevant experience; or advanced degree with 5+ years of relevant experience.

Preferred Qualifications:

• 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 computervision 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. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

Salary ranges for U.S (excl. PR) locations (USD):$138,000.00 - $234,000.00

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).

This position is eligible for a short-term incentive called the Short Term Incentive (STI).

At MiniMed, we are committed to supporting the well-being and financial security of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In addition, all regular employees enjoy incentive plans, a 401(k) plan with company match, 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. Please note that "regular employees" refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico.

For further details about our comprehensive benefits, we encourage you to visit the link below.

MiniMed Benefits Overview

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.

Learn more about our business, and our mission here.

It is the policy of MiniMed to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, familial status, membership or activity in a local human rights commission, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law. In addition, MiniMed will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week