Mainstay Medical · 15 hours ago
Systems Engineer
San Diego, CA
Full-time
Onsite
Mid Level
$90K/yr - $120K/yr
3+ years expMainstay Medical is a medical device company focused on marketing an innovative implantable neurostimulation system for chronic low back pain. The Systems Engineer will support projects through a structured product development program, collaborating with various engineering and regulatory teams to ensure successful project execution and compliance with design controls.
BiotechnologyEmergency MedicineHealth CareMedicalMedical Device
Responsibilities
Collaborate with fellow engineers in the Product Development group as well as partners in Quality, Regulatory and Marketing to support project execution through various phases of the product development life cycle
Leverage your background in biomedical, systems, software, and/or other engineering fields to support the execution of design control activities and tasks for existing products and new products from concept to launch
Be responsible for eliciting stakeholder needs, goals and objectives and translate them into formal customer, clinical, regulatory, and business requirements
Decompose high level stakeholder needs into singular, testable, unambiguous, necessary, feasible, complete, and consistent system and subsystem requirements
Support risk management activities by following ISO 14971 and similar processes
Lead design reviews and verification/validation and related activities including planning, resource allocation, protocol creation, test execution and documentation
Review technical decisions and design strategy for alignment with stakeholder needs, risk minimization, and prevention of subsystem-interface conflicts. Identify tradeoffs of potential design decisions and convey the risks and benefits of those decisions
Support human factors/usability activities according to FDA and MDR guidance and recognized consensus standards
Ensure all stakeholder needs, requirements, and risk controls are satisfied; and traceability is properly documented
Create and maintain design history files
Analyze proposed changes to products and provide a detailed impact analysis to ensure successful and predictable implementation
Support and lead failure investigations including root cause analysis and associated CAPA activities. Participate in troubleshooting issues during product development and post product release
Complete other related duties as assigned
Qualification
Required
Minimum 3 years experience as a Systems Engineer, Validation/Test Engineer or related role under a regulated medical device environment
Minimum Bachelors degree in Biomedical, Systems, Mechanical, Electrical, Software, Controls, or other technically relevant field
Demonstrated ability to work cohesively with cross-functional team members to meet common engineering and product development goals
Strong written and verbal communication skills in an engineering and product development environment
Familiarity with FDA design controls guidance
Knowledge of Risk Management processes following ISO 14971
The ability to quickly learn complicated new systems, accurately describe and diagram those systems, and verbally explain their intricacies and interfaces to a variety of audiences with different technical or non-technical backgrounds
Preferred
Demonstrated success applying formal Systems Engineering principles and Systems thinking to Engineering and Product Development projects
Experience working with FDA Class III or EU MDR Class III devices
Previous experience with the following additional standards and regulations: EU MDR, TGA EP, UK AIMDD, IEC 60601-1 series, IEC 62304, IEC 62366-1, IEC 20417, ISO 10993, ISO 10974, ISO 11607, ISO 14708-1 / EN 45502-1, AAMI TIR57, 21 CFR 15, RoHS, REACH, EU RED, ETSI series, and AS/NZS 4268
Familiarity with one or more software tools for the management of requirements, (product/project) risks, verification, validation, etc. (e.g., Doors, Polarian, Jama, Matrix)
Familiarity with INCOSE and NASA Systems Engineering Handbook
Competent in a programming/scripting language for use in automating data processing, test execution, reporting, and other related activities (e.g, Python, Matlab, VB for Excel, Labview, etc)
Experience designing, building, reviewing, and validating fixtures to support testing
Familiarity with the FDA's cybersecurity guidance, risk management approach, and cybersecurity testing
Software Development and/or Software Testing knowledge and skills, including use of revision control systems
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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