Principal Software Quality Engineer

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

The Principal Software Quality Engineer works as part of the core new product development team to lead software quality activities for digital health solutions, including mobile applications (iOS/Android), web applications, and cloud-based data-driven solutions. The candidate must possess deep expertise in software development life cycle processes (Waterfall/Agile/DevOps) as applied within the regulated medical device industry. This is a Hybrid role based in Northridge, CA

Responsibilities May Include the Following and Other Duties May Be Assigned

Core Team Member

• Lead as a quality core team member responsible for driving quality into the design and development of digital health solutions including medical mobile device applications (iOS/Android), web applications, cloud technologies (AWS/IBM Watson), data reports, and AI/ML solutions; lead the collaborative quality strategy for projects in alignment with business goals for cross-functional teams including R&D, Med Safety, Regulatory, Marketing, and DevOps.

Software Evaluation and Compliance

• Leads quality oversight and evaluation of software systems activities across the software development lifecycle (Agile/Waterfall/DevOps) including requirements, design, development, documentation, integration, test, verification and validation; leads design reviews and reviews and approves design input/design output artifacts ensuring project and process control documentation comply with procedural requirements, applicable standards and regulations, with full requirement traceability maintained and documented.

Risk Management & Defect Management

• Lead and conduct risk management activities including system risk analysis and software FMEAs; manages and triages software issues with the cross-functional teams.

Quality Standards & Program Development

• Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures; develops overall operating criteria to ensure implementation of the software quality program according to project, process, and contract requirements and objectives.

CAPA & Quality Improvement

• Lead and drive CAPA (Corrective and Preventative Action) projects; lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures.

Audits & Regulatory Compliance

• Participate in both internal and external regulatory audits and inspections; and supports Quality Management System reviews of Standard Operating Procedures aligned with US and international standards.

Post-Market Support

• Supports post-market team for FCAs or HRAs as needed.

Qualifications

Must Have: Minimum Requirements

• Bachelor’s degree in engineering, Science, or Technical Field with 7+ years of relevant experience in Quality, Engineering, and/or Software Development OR
• Advanced Degree in Engineering, Science, or Technical Field with 5+ years of relevant experience in Quality, Engineering, and/or Software Development.
• Must have working knowledge of medical device compliance standards including ISO 13485, IEC 62304, HIPAA, FDA QMSR, Security Standards, and Data Privacy regulations
• Ability to author technical reports, business correspondence, and standard operating procedures

Nice to Have

• Experience in software design and development, verification, validation, and testing activities for mobile application development (and/or web applications and cloud infrastructure services (Amazon AWS/Microsoft Azure).
• Experience executing in the SDLC environment leveraging ALM tools (e.g., PTC Integrity/Atlassian Suite/TFS), defect tracking tools (e.g., Jira/PTC)
• Exposure to wireless communication protocols (e.g., Bluetooth).
• Working knowledge of integrated digital health systems including consumer products such as Apple/Android products.

• CQE or CSQE Certification preferred.

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.

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).

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.