Senior development engineering

R-801101We anticipate the application window for this opening will close on - 7 Jul 2026**Job Description:**Responsible for providing R&D and quality engineering support to ensure the successful development of MiniMed devices, design transfers, scale-up and ongoing operational support. Work with Design and Quality control on product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices. Navigate complex regulations and standards including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO 13485, ISO 10993-1, and American Society for Testing and Materials (ASTM) D4169. Responsible for pre and post Market risk analysis activities including Fault Tree Analysis, Process and Design Failure Mode Analysis (PFMEA and DFMEA), and Corrective and Preventative Actions (CAPA). Analyze post-market surveillance data, investigate and respond to complaints. Responsible for the development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) and Gage R&R. Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) in association with technical report creation and Engineering Change Order (ECO) routing. Leverage 2D Drafting and 3D Modeling using CADs software for design of robust and manufacturable device components including plastic injection molding, utilizing SolidWorks and Geometric Dimensioning and Tolerancing (GD&T) application. Job Requirements:**Requires a Master’s degree in Mechanical, Industrial, Chemical or Biomedical Engineering or related engineering field plus two (2) years of experience in R&D Engineer or related occupation for medical devices.Product design, verification and validation testing, test method development, and manufacturing transfer support for Class II and Class III medical devices;· Risk analysis activities including Fault Tree Analysis, PFMEA, DFMEA, and CAPA· Analyzing post-market surveillance, investigating and responding to complaints· DOE, Sampling Techniques, and statistical analysis· IQ/OQ/PQ and Gage R&R· ECOs, technical reports, and compliance with GMP and GDP.· 2D Drafting and 3D Modeling using CADs software for design of robust and manufacturable device components including plastic injection molding, utilizing SolidWorks, GD&T application.**Benefits & Compensation**MiniMed offers a competitive salary and flexible benefits package.They share in the success they help create. PR) locations (USD): $105,000.00 to $125,000.00Actual 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).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. About MiniMed**We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.#LI-DNI### Who we areMiniMed 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. With a heritage rooted in technology, empathy, and a relentless pursuit of innovation, we’re focused on one thing: making every day a better day for people with diabetes.From our intelligent dosing systems that stay one step ahead to our always-on support when it’s needed most, we’re committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. And more freedom to live in the moment.### What we doWe’re here to make better days possible for people with diabetes.For more than four decades, we’ve been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they're living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier.### At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career-building resources you might need.**Our life-transforming technologies.**No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day-to-day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms.**We're chasing the dream of a world where people with diabetes can be free of that never-ending battle of balancing blood sugar. Fresh faces and new viewpoints will help create our cutting-edge solutions and define the next generation of breakthroughs in care, so that a better day can start today.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, 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.

#