Senior Software Quality Engineer

About the Role

The Senior Software Quality Engineer works as part of the core product team to collaboratively drive the software development activities for embedded firmware and lead the risk management assessment and Quality deliverables. Candidate will work with the R&D team to drive quality into product development, including collaborating with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality, and implement strategies that enable continuous improvement.

Responsibilities

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

• Hybrid role based in Northridge, CA
• Participate in product risk management activities including software Failure Mode Effects Analysis (FMEA) and product hazard analysis.
• Drive quality compliance with R&D team, including design controls, risk management, and change control processes, and engaging as Quality core team member with cross functional team members.
• Participate in technical and product design reviews.
• Review design input and output artifacts including requirements, design documents, code reviews, verification and validation reports.
• Manage and triage software issues with R&D team
• Participate and support Quality Management System reviews of Standard Operating Procedures which align with US and international standards
• Ensure that all requirement traceability is met and documented appropriately
• Strong verbal and written communication skills with an ability to effectively communicate at multiple hierarchical levels in the organization.
• Support CAPAs as needed, and post-market team for FCAs or HRAs as needed
• Support internal and external audits

Must Have

Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor's degree in Engineering, Science or Technical field with 4+ years of relevant experience in Quality, Engineering and/or Software Development
• Advanced Degree in Engineering, Science or Technical field with 2+ years of relevant experience in Quality, Engineering and/or Software Development

Nice To Have

Understanding of software development life cycle processes as applied to embedded firmware within the regulated medical device industry, and be familiar with IEC 62304, 13485, 14971, and FDA QMSR. Candidate must have strong verbal and written communication skills. #BetterDaysStartNow

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.

Salary ranges for U.S (excl. PR) locations (USD):118000.00

For roles located in California, Seattle WA, Washington DC, Boston MA, and New York City, the salary range is $97,000 - $165,000 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).

• health, dental, and vision insurance
• access to a Health Savings Account
• Healthcare Flexible Spending Account
• life insurance
• long-term disability leave
• a dependent daycare spending account
• 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
• access to our Employee Assistance Program
• Non-qualified Retirement Plan Supplement
• Capital Accumulation Plan

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.