Senior Biomedical Engineer
About The Position
As a member of MiniMed’s Continuous Glucose Monitoring Sensor R&D team, the Senior Biomedical Engineer contributes to the development of biosensing technologies and manufacturing, with an emphasis on glucose sensing. The role focuses on sensor technology design, manufacturing processes, and optimization, and requires a deep understanding of how wearable electrochemical sensor components and tissue interactions affect performance, manufacturability, and reliability. The engineer contributes to design transfer into manufacturing by developing statistically robust in-process check specifications, sample-size determinations, and substrate rejection criteria in collaboration with engineering, quality, and regulatory teams. The role also applies data analysis, statistical methods, and machine-learning tools to improve process monitoring and sensor performance. The engineer uses real-world sensor performance insights to support continuous improvement and inform next-generation sensing platform designs. This experienced technical contributor independently plans and conducts experiments, analyzes data, documents results, and communicates effectively with internal and external stakeholders, including senior leaders. The role works across a multidisciplinary team, supports design development and process transfer, mentors scientists and engineers, and ensures work complies with applicable quality systems, design controls, medical-device standards, and regulatory expectations.
Requirements
- Bachelor’s degree with at least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
- Hands-on experience in sensor design, first-principles problem solving, structured experimentation, and data-driven decision-making.
- Expertise in advanced statistical methods, including DOE, ANOVA, mixed-effects models, hypothesis testing, SPC, process capability, MSA/Gauge R&R, and sample-size or power analysis.
- Proficiency in Python, including Pandas, NumPy, and SciPy, and in SQL.
- Ability to influence technical and business decisions across cross-functional teams.
- Excellent written and verbal communication skills, including the ability to explain complex analytical topics to senior leaders and technical teams.
Nice To Haves
- Experience developing glucose, biosensor, electrochemical, wearable, or related medical-device sensors, with knowledge of how design parameters such as electrode geometry, enzyme loading, and membrane stacks affect performance, reliability, and manufacturing feasibility.
- Experience with pFMEA, control plans, and sampling-plan design in a high-volume manufacturing context.
- Familiarity with analytical method transfer and equipment or 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 for manufacturing inspection or sensor characterization.
- Experience with machine learning.
- Experience with project management and relevant tools.
- Familiarity with JMP or Minitab.
- Knowledge of machine-learning libraries such as scikit-learn, PyTorch, or OpenCV.
Responsibilities
- Contribute to design transfer activities, including defining and refining statistically robust in-process check specifications, sample-size determinations, and rejection criteria.
- Develop and apply advanced statistical analyses and data-driven investigations to support sensor process optimization, performance modeling, and manufacturing decisions.
- Perform detailed engineering analyses and prepare documentation to support design development and process transfer.
- Apply first-principles understanding of glucose sensor behavior, including electrochemistry, enzyme-mediated sensing, mass transport, membrane design, tissue interface, interferents, drift, and stability.
- Use data analysis and statistical methodologies to generate sensor-performance insights, guide experiment design, and inform project next steps.
- Apply analytical tools, including statistical learning methods where appropriate, to support defect detection, classification, and improvements to sensor process monitoring.
- Apply data-management and data-visualization best practices to build data pipelines and analytics tools.
- Use Six Sigma, Lean, DRM/DFSS, and other appropriate continuous-improvement techniques.
- Work with engineers and technicians to execute experimental designs and analyses.
- Mentor scientists and engineers in rigorous experimental design and first-principles technical decision-making.
- Ensure work complies with applicable quality-system requirements, design controls, medical-device standards, and regulatory expectations.
- Communicate results and technical insights to internal and external stakeholders, including upper management.
Benefits
- Competitive salary and flexible benefits package.
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account access.
- Healthcare Flexible Spending Account access.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Incentive plans.
- 401(k) plan with company match.
- Short-term disability coverage.
- Paid time off and holidays.
- Employee Stock Purchase Plan participation.
- Employee Assistance Program access.
- Eligible employees may also receive access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
