Senior Systems Engineer

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 were revolutionizing an industry and changing lives. Were impacting what the future of dialysis looks like by creating a firstofitskind 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. Were giving providers time back to focus on patient care. And were 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 handson experienced engineer who will help define the architecture development and V&V testing of next generation complex electromechanical medical devices while supporting onmarket 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 riskbased priorities for verification and validation testing to ensure that critical system functions and features are thoroughly evaluated.
• Lead the 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 crossfunctional 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 decisionmaking and problemsolving.

Requirements/Qualifications

• Bachelors or Masters 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 problemsolving and decisionmaking 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 112 etc..
• Familiarity with software development and C/C.

Company Culture

At Outset we believe every person matters. Every Outsetter every patient every caregiver. Because we are here to create a revolution and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills and we find joy in working together for a common goal. At Outset we believe that curiosity ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU our future Outsetter. At Outset weve designed a professional world that our employees are honored and impassioned to belong to one that offers challenge the ability to collaborate with great people and opportunities to build skill and expertise in a fulfilling career.

An opportunity at Outset Medical wont just be about finding a job. Our culture revolves around the principles of moving farther faster together so working here feels like a masterclass in peak performance for individuals and teams.

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Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note Outset Medical will never request payment or gift cards during the hiring process nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @ is not a legitimate Outset representative. For legitimate opportunities always apply directly through our official careers page. If you are unsure about the authenticity of a communication contact us immediately at .

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race color national origin religion gender gender identity sexual orientation disability genetic information pregnancy age or any other protected status set forth in federal state or local laws. This policy applies to all employment practices within our organization.