Biomedical Manufacturing Engineer II

MiniMed Group; California, Northern (MO, KY); Hybrid; USD 87,000 - 149,000; Full time

Benefits offered by this job

Competitive benefits

On-site role in Northridge

Job summary

MiniMed is hiring a Biomedical Engineer II for an on-site role in Northridge, California. You will join Operations Engineering to help bring medical devices from concept to high-volume production, collaborating with R&D, Quality, Manufacturing and Supply Chain.

The role emphasizes process validation, DOE, data analysis, and documentation. The position requires a biomedical or mechanical engineering background and at least two years of relevant experience, with travel up to 40%.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field with 2+ years of relevant experience.
• Direct experience with technical documentation including engineering reports, SOPs, test protocols, and lab notebooks.
• 30-40% travel domestically and/or internationally.

Responsibilities

• Support setup, installation, and qualification of new production equipment and lines (IQ/OQ/PQ).
• Contribute to process validation protocols and prospective validation studies.
• Design and develop fixtures and tooling using SolidWorks and maintain drawings.
• Perform DOE studies to model CTQ variability and guide decisions.
• Assist TMV protocol authoring and execution for measurement system validation.
• Apply data analysis and statistics, including process capability and yield tracking, using Minitab.
• Support cost savings initiatives and collaborate with cross-functional teams.
• Maintain engineering records and participate in root cause analysis with quality, manufacturing and R&D.

Skills

Documentation skills

DOE

Data analysis

Statistical methods

SolidWorks

Minitab

Root cause analysis

Lean Manufacturing

Education

Biomedical Engineering

Mechanical Engineering

Tools

SolidWorks

Job description

MiniMed is hiring a Biomedical Engineer II for an on-site role in Northridge, California. You will join Operations Engineering to help bring medical devices from concept to high-volume production, collaborating with R&D, Quality, Manufacturing and Supply Chain.

The role emphasizes process validation, DOE, data analysis, and documentation. The position requires a biomedical or mechanical engineering background and at least two years of relevant experience, with travel up to 40%.