COMPANY OVERVIEW

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve “better” now, not some day.
At Outset we’re revolutionizing an industry and changing lives. We’re impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We’re giving providers time back to focus on patient care. And we’re giving patients the power to take control of their life and get back to enjoying the things they love.

POSITION OVERVIEW

The Senior Systems Engineer will lead the design, development, and validation of complex medical devices, leveraging their expertise in systems engineering principles and practices. The ideal candidate will be a hands-on experienced engineer who will help define the architecture development and V&V testing of next generation complex electromechanical medical devices while supporting on-market products.

Essential Job Functions and Responsibilities

• Lead the elicitation, analysis, and documentation of system requirements in collaboration with stakeholders, ensuring alignment with user needs, regulatory standards, and business objectives.
• Establish and maintain traceability between requirements, design specifications, and verification/validation activities throughout the product development lifecycle.
• Facilitate requirements review meetings and manage changes to requirements in accordance with established change control processes.
• Develop comprehensive verification and validation plans and protocols based on system requirements, design specifications, and regulatory requirements.
• Define test strategies, test cases, acceptance criteria, and test procedures for verification and validation activities, ensuring adequate coverage of system functionality and performance.
• Establish risk-based priorities for verification and validation testing to ensure that critical system functions and features are thoroughly evaluated.
• Lead the execution of verification tests using advanced tools and methodologies.
• Analyze test results and verify that the system meets functional, performance, and safety requirements, documenting test protocols, results, and deviations.
• Provide technical guidance and mentorship to junior engineers and testers on verification testing practices and techniques.
• Lead risk management activities, including risk assessments, hazard analyses, and risk mitigation strategies, to identify, evaluate, and mitigate potential hazards and risks associated with the medical device.
• Leads hardware CCB (Change Control Board) meetings and participates in software CCB meetings.
• Collaborate closely with cross-functional teams, including software engineers, hardware engineers, quality assurance specialists, and regulatory affairs professionals, to ensure alignment and integration of system requirements and verification/validation activities.
• Communicate effectively with team members and stakeholders to provide updates on project status, milestones, and risks, and to facilitate decision-making and problem-solving.

Requirements/Qualifications

• Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, Computer Engineering, or a related field.
• 5+ years of experience in systems engineering, with a focus on medical device development and verification/validation.
• Expertise in systems engineering principles, requirements management, verification/validation methodologies, and risk management practices.
• Proficiency in requirements management tools (e.g., DOORS), issue tracking systems (e.g., JIRA), and test management software.
• Strong leadership, problem-solving, and decision-making skills, with the ability to effectively manage multiple projects and priorities.
• Excellent interpersonal and communication skills, with the ability to collaborate effectively with multidisciplinary teams and external stakeholders.
• Understanding of statistical tools (Minitab, etc.).

DESIRABLE SKILLS

• Programming skills in scripting languages such as Python, MATLAB, or LabVIEW for developing automated test scripts and data analysis tools.
• Familiarity with medical device standards (60601-1, 60601-1-2, etc.).
• Familiarity with software development and C/C++.

• Lead the elicitation, analysis, and documentation of system requirements in collaboration with stakeholders, ensuring alignment with user needs, regulatory standards, and business objectives.
• Establish and maintain traceability between requirements, design specifications, and verification/validation activities throughout the product development lifecycle.
• Facilitate requirements review meetings and manage changes to requirements in accordance with established change control processes.
• Develop comprehensive verification and validation plans and protocols based on system requirements, design specifications, and regulatory requirements.
• Define test strategies, test cases, acceptance criteria, and test procedures for verification and validation activities, ensuring adequate coverage of system functionality and performance.
• Establish risk-based priorities for verification and validation testing to ensure that critical system functions and features are thoroughly evaluated.
• Lead the execution of verification tests using advanced tools and methodologies.
• Analyze test results and verify that the system meets functional, performance, and safety requirements, documenting test protocols, results, and deviations.
• Provide technical guidance and mentorship to junior engineers and testers on verification testing practices and techniques.
• Lead risk management activities, including risk assessments, hazard analyses, and risk mitigation strategies, to identify, evaluate, and mitigate potential hazards and risks associated with the medical device.
• Leads hardware CCB (Change Control Board) meetings and participates in software CCB meetings.
• Collaborate closely with cross-functional teams, including software engineers, hardware engineers, quality assurance specialists, and regulatory affairs professionals, to ensure alignment and integration of system requirements and verification/validation activities.
• Communicate effectively with team members and stakeholders to provide updates on project status, milestones, and risks, and to facilitate decision-making and problem-solving