Senior Software Quality Engineer
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Before you apply
Salary$118k – $149k
LocationNorthridge, California, United States of America; San Diego, California, United States of America
Work modeon-site
Typefull-time
SenioritySenior
Experience2+ yrs
DepartmentQuality
Company size10,000+ people
First seenSep 27, 2026 · 1mo ago
Verified live15h ago
At a glanceSummarised by Seekless from the posting.
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
Understanding of software development life cycle processes as applied to embedded firmware within the regulated medical device industry
Familiar with IEC 62304, 13485, 14971, and FDA QMSR
Strong verbal and written communication skills
We anticipate the application window for this opening will close on - 4 Dec 2026
About the company
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 Senior Design Quality Engineer serves as a quality partner within the core product development team, driving design quality, risk management, and compliance throughout the product lifecycle. This role is distinct from software development and software testing and focuses on design controls, risk management, and quality systems.
The candidate will collaborate cross-functionally with R&D software development and test, Regulatory, Marketing, Medical Safety, and Post-Market Quality to integrate quality principles and risk management into product development and implement strategies that enable continuous improvement.
Ready to make an impact? Apply now and join our team!
Responsibilities may include the following and other duties may be assigned.
Hybrid role based in Northridge, CA or San Diego, CA
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Participate in product risk management activities including software Failure Mode Effects Analysis (FMEA) and product hazard analysis.
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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.
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Participate in technical and product design reviews. Review design input and output artifacts including requirements, design documents, code reviews, verification and validation reports.
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Manage and triage software issues with R&D team
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Participate and support Quality Management System reviews of Standard Operating Procedures which align with US and international standards
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Ensure that all requirement traceability is met and documented appropriately
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Strong verbal and written communication skills with an ability to effectively communicate at multiple hierarchical levels in the organization.
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Support CAPAs as needed, and post-market team for FCAs or HRAs as needed
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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.
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Bachelor’s degree in Engineering, Science or Technical field with 4+ years of relevant experience in Quality, Engineering and/or Software Development OR Advanced Degree in Engineering, Science or Technical field with 2+ years of relevant experience in Quality, Engineering and/or Software Development.
Nice To Have:
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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.
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Candidate must have strong verbal and written communication skills.
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