Mainstay Medical · 13 hours ago
Principal Software Quality Engineer
San Diego, CA, US
Full-time
Onsite
Lead/Staff
$134K/yr - $159K/yr
8+ years expMainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system, ReActiv8®, for people with disabling chronic mechanical Low Back Pain. The Principal Software Quality Engineer is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for Class III products and Software as a Medical Device, ensuring compliance with applicable standards and improving processes.
BiotechnologyEmergency MedicineHealth CareMedicalMedical Device
Responsibilities
Lead Design Control and Software Development Quality projects and initiatives to ensure appropriate Design History File documents for Class III medical devices, mobile medical applications (MMAs), cloud-based systems, and cybersecurity controls. This includes providing timely guidance and expertise during creation and review of software development artifacts such as software requirements, architecture, design documentation, risk management, planning documentation, V&V protocols/reports, and release notes; and evaluating design updates and impact assessments for software updates
Ensure software development and maintenance comply with regulatory standards including FDA revised 21 CFR Part 820 (QMSR), ISO 13485, IEC 62304/82304, ISO 14971, and IEC 62366, and other applicable guidances related to software, firmware, and software as a Medical Device (SaMD)
Support creation of necessary documentation to comply with regulatory requirements and industry best practices, including creation and maintenance of Software Development Lifecycle (SDLC) procedures and work instructions
Ensure design control deliverables meet regulatory expectations for premarket submissions and audits and support creation of necessary documentation to comply with regulatory requirements and industry best practices. Support efforts for cybersecurity and security risk management for both US and global requirements, as applicable where product is commercialized
Support internal and external audits, including FDA inspections and notified body ISO audits
Support and contribute to execution of risk management activities in compliance with ISO14971 and software risk requirements in IEC 62304
Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
Provide guidance on and participate in software development activities including design and code reviews, risk reviews, requirements analysis and tracing, defect tracking and investigation, and configuration management
Perform quality supplier management and support of software contractors, as required
Qualification
Required
B.S. degree in engineering/scientific/computer systems, or related field
A minimum of 8+ years work experience in Quality Engineering within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience
A minimum of 5+ years experience with medical device software development, including software mobile medical applications (MMAs), firmware, cloud-based systems, and cybersecurity
Experience in the development and implementation of effective Design Control Systems, including working knowledge of QMSR (revised FDA 21 CFR Part 820) and ISO 13485 quality system standards, and SDLC per IEC 62304
Strong knowledge of risk management and usability engineering standards (ISO 14971, IEC 62366)
Excellent communication, technical writing, and cross-team collaboration skills
Preferred
ASQ, CSQE or other software quality certificates are beneficial
Working knowledge of data privacy requirements in U.S. and EU (GDPR) desired
Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and premarket regulatory submission requirements
Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.)
Experience coordinating or leading audits beneficial
Benefits
Medical
Dental
Vision
Financial
Other benefits
Equity
Company
Mainstay Medical
Mainstay Medical is a global medical device company that is developing devices to deliver innovative therapies.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$395.44MKey Investors
Oxford Finance LLCKCKIPF Partners
2024-02-26Private Equity· $125M
2021-04-20Debt Financing· $50M
2021-02-16Private Equity· $108M
Leadership Team
Jason Hannon
Chief Executive Officer
Prashant Rawat
COO
Recent News
BioWorld Financial Watch
2025-04-30
Business Wire
2025-04-28
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