Biomedical Engineer II

MiniMed•Northridge, CA

8d•Onsite

About The Position

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 MiniMed 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.

Requirements

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 protocols, and laboratory/engineering notebooks

Nice To Haves

Demonstrated written and verbal communication skills, with the ability to present experimental results and analytical findings clearly to project teams
Demonstrated ability to work both independently on assigned tasks and collaboratively with a cross functional team
Familiarity with quality system requirements, design controls, and good manufacturing practices in a regulated medical device or cGMP environment
Demonstrated foundational knowledge for fixture design and prototyping
A general understanding of what process validation looks like in medical device manufacturing — why it matters, how it's structured, and how equipment and processes move through qualification stages to reach a validated state
Familiarity with Lean Manufacturing or Six Sigma concepts and terminology
Exposure to injection molding, ultrasonic welding, or other medical device manufacturing processes
Exposure to working with suppliers, equipment manufacturers, or contract manufacturers
Familiarity with root cause analysis tools (5-Why, Fishbone, Fault Tree)

Responsibilities

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 SolidWorks; 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