Systems Engineer

Mainstay 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 company is headquartered in Dublin, Ireland, with subsidiaries operating in the United States, Australia, the United Kingdom, and Germany.

This position is onsite in San Diego.

The Systems Engineer position is part of Mainstay Medical’s Product Development department. Your contributions at Mainstay are at the intersection of mechanical, electrical, software and biomedical engineering and draws from principles from each discipline. The Systems Engineer is primarily responsible for successfully supporting projects through a structured and regulated product development program, working closely with other functional leads in Engineering, Regulatory/Quality and Marketing.

• 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.

• 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.

• 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 TIR
  57, 21 CFR 11, RoHS, REACH, EU RED, ETSI series, and AS/NZS 4268.
• Familiarity…