Biomedical Engineer II
$87k - $149kBurlington Coat Factory
We anticipate the application window for this opening will close on - 7 Oct 2026
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 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. 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 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
- 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
- 30-40% domestic and/or international travel
- 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 manufacturersFamiliarity with root cause analysis tools (5-Why, Fishbone, Fault Tree)
Salary ranges for U.S (excl. PR) locations (USD):$87,000.00 - $149,000.00 For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $87,000 - $149,000 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 within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. MiniMed will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Vacancy posted 20 hours ago
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