Testing Systems Engineering

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.The Role: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.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.Ensure all stakeholder needs, requirements, and risk controls are satisfied; and traceability is properly documented.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. Minimum Qualifications: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.Knowledge of Risk Management processes following ISO 14971.Preferred Qualifications:Demonstrated success applying formal Systems Engineering principles and Systems thinking to Engineering and Product Development projects.Familiarity with one or more software tools for the management of requirements, (product/project) risks, verification, validation, etc. (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.however, base pay offered will take into account a range of factors, including job-related knowledge, skills, and experience. The total compensation package includes a range of medical, dental, vision, financial, and other benefits, as well as equity.Mainstay Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.