Sr. Quality Engineer

PRI-MiniMed Puerto Rico Operations Company; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

STI program

Flexible benefits package

Job summary

MiniMed is seeking a Sr Quality Engineer I to actively support compliant, efficient, patient-focused medical device manufacturing operations. You will lead investigations, handle nonconformances, and partner across functions in a regulated quality environment.

Responsibilities include developing quality standards, supporting document control, and implementing testing methods while ensuring proper documentation and reliability of processes and products.

Qualifications

• Engineering Bachelor Degree is required.
• Minimum 4 years of relevant experience, or 2 years with an advanced degree.

Responsibilities

• Develops, applies and maintains quality standards and protocol for processing materials into finished products.
• Collaborates with engineering and manufacturing to ensure quality standards are in place.
• Designs inspection/testing mechanisms; conducts quality assurance tests and statistical analyses.
• Ensures corrective actions meet reliability standards and documentation remains compliant.

Skills

Quality assurance

Root cause analysis

Process validation

Statistical analysis

Education

Engineering degree (Mechanical / Electrical / Chemical)

Tools

Minitab

pfMEA / risk management

URS / FAT / IQ / OQ / PQ

Job description

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

Join MiniMed as a Sr Quality Engineer I and play a hands-on role in keeping our medical device manufacturing operations compliant, efficient, and patient-focused. You'll tackle nonconformances, drive investigations, support document control, and partner cross-functionally to resolve issues at the source - all in a regulated environment where quality truly matters.

Responsibilities

Responsibilities may include the following and other duties may be assigned.

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Must Have

Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume. Requires Engineering Bachelor Degree Requires minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Nice to Have

• Experience with Risk management documentation: pFMEAs
• Basic knowledge in statistics (preferably using Minitab)
• Basic knowledge in designing validation strategies (e.g requirements flow down from design to manufacturing)
• Engineering degree: Mechanical, Electrical or Chemical preferred
• Experience investigating manufacturing operations events in support for product disposition
• Experience assessing and tracing manufacturing defects/rejects trends
• Perform and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory)
• Knowledge in Medical Devices regulations
• Experience with projects: design requirements validation, manufacturing controls

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co‑workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

MiniMed offers a competitive salary and flexible benefits package.

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. This position is eligible for a short-term incentive called the Short Term Incentive (STI).

MiniMed Benefits Overview

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.

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. 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. Fewer second guesses. And more freedom to live in the moment. We’re here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier. 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. Our people‑first priority. 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. Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never‑ending battle of balancing blood sugar. A world where better days are the norm, not the exception. 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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here.