Biomedical Engineer II

## Biomedical Engineer IIApply:
On-Site:
Northridge, California, United States of America:
Full time:
Posted Yesterday:
End Date:
October 7, 2026 (12 days left to apply):
R-801884

We anticipate the application window for this opening will close on - 7 Oct 2026

At Mini Med, 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
** Operations Engineering sits at the intersection of product design, manufacturing, and quality — serving as the engineering backbone that brings medical devices from concept into reliable, high-volume production. Our team is responsible for ensuring that production equipment, processes, and tooling meet the rigorous standards required in a regulated medical device environment.
As Mini Med continues to scale and innovate in diabetes care technology, Operations Engineering plays a critical role in launching new production lines, optimizing existing processes, and maintaining the validated state of our manufacturing systems. Engineers on this team collaborate closely with R&D, Quality, Manufacturing, and Supply Chain to products to the patients who depend on them every day.
We are a team that values technical excellence, intellectual curiosity, and mentorship — where engineers work alongside a cross functional team to build deep expertise across mechanical design, process engineering, automation, and lean manufacturing.  
** Responsibilities may include the following and other duties may be assigned.
** Full-time on-site role in Northridge, CA  
* Support the setup, installation, and qualification (IQ/OQ/PQ) of new production equipment and manufacturing lines under the guidance of senior engineers
* Contribute to the development and execution of process validation protocols, assisting with prospective validation studies to ensure manufacturing processes consistently produce conforming product
* Conduct DOEs to characterize process parameters and model statistically significant critical-to-quality (CTQ) output variability with respect to process and environmental inputs, collaborating with senior team members on experimental strategy
* Support the authoring and execution of test method validation (TMV) protocols to ensure measurement systems are accurate, precise, and reproducible
* Design and develop custom fixtures and tooling using Solid Works; create and maintain engineering drawings through revision control
* Apply data analysis and statistical methodologies — including process capability, hypothesis testing, and yield tracking — to generate insights and inform project decisions, using tools such as Minitab
* Execution of cost savings initiatives for production
* Work with Quality, Manufacturing, R&D, and Facilities teams to support root cause analysis
* Maintain accurate and complete engineering records, including protocols, reports, SOPs, and engineering change orders, in compliance with applicable quality system requirements
* Contribute to the completion of project milestones under the guidance of senior engineers, developing technical depth and breadth through mentored project work  
** Must Have:

Minimum Requirements *
* *** To be considered for this role, please ensure the minimum requirements are evident on your resume.
**** Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a closely related engineering discipline with 2+ years of relevant experience; or advanced degree with 0+ years of relevant experience
* Direct experience with technical documentation including engineering reports, standard operating procedures, test…