Shifamed · 2 days ago
Staff/Principal Software Quality Engineer
Campbell, CA
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $200K/yr
8+ years expShifamed is a privately held medical technology incubator focused on developing novel medical products. They are seeking a Staff/Principal Software Quality Engineer to drive quality into software product development at Laza Medical, working with cross-functional teams within the regulated medical device industry.
Health CareMedical Device
Responsibilities
Lead as a quality core team member responsible for driving quality into the design and development of software solutions
Lead quality focused design and development of software within the software development lifecycle (Agile/Waterfall/DevOps) by defining the requirements, design, verification and validation plan and strategies while maintaining traceability
Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review, test results, verification and validation reports and defects
Lead and conduct risk management activities including system risk analysis and software FMEA’s
Participate in both internal and external regulatory audits and inspections
Manage compliance to standards for software quality operating methods, processes, and procedures (such as ISO 13485, IEC 62304, AAMI TIR 45, Security Standards, and Data Privacy)
Qualification
Required
Bachelor's degree in Engineering, Science or Technical Field with a minimum of 8+ years of experience in Engineering and/or Quality
Experience with software quality engineering activities for new product development
Ability to author technical reports, and standard operating procedures
Exposure to medical imaging solutions leveraging machine learning/ artificial intelligence (AI)
Demonstrated ability to support multiple projects
Benefits
Equity
Benefits
Company
Shifamed
Shifamed is a progressive medical technology incubator that combines human-centered design.
201-500 employees
H1B Sponsorship
Shifamed has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2021 (2)
Funding
Current Stage
Growth StageLeadership Team
Claudio Argento
CTO
Mariam Maghribi
Chief Business Officer
Recent News
2025-10-01
2025-08-13
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