Medical Device Senior Principal Test Engineer - Ventilation

Medical Device Senior Principal Test Engineer - Ventilation Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are an energetic company with a long history of revolutionary products. We devise outstanding solutions that allow patients to lead ordinary lives. We believe the best way to create new value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, establishing last relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference. To learn more, visit our website: www.vyaire.com Watch our video: https://youtu.be/vE6nTH_FElA The Impact You’ll Make in this Role As a(n) Senior Principal Test Engineer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Work with sustaining and new product teams in developing and execution of verification test plans, protocols, scripts, test cases and reports Drive quality into the product development process through analysis and timely feedback of test results to the design teams Working with the team, manage defect issues working with field correction actions, CAPA, and issue tracking tools such as JIRA and JAMA Design test cases to include test methodology, test setups, materials, equipment, test procedure, and requirements acceptance criteria Develop test plans, protocols, scripts, test cases, and reports to fully verify product level system requirements, and regulatory compliance requirements for agency standards such as ISO, IEC, and FDA Conduct system level software testing, analyze issues, and verify bug fixes Document, manage and maintain test records consistent with formal verification process and QMS Participate in multi-functional team meetings and design reviews Provide test mentorship and direction to technicians and engineers Build and validate test fixtures and test systems needed for product design verification Solve and support resolution to system operational issues pertaining to software and hardware discrepancies, and interoperability with supplier third-party software Your Skills and Expertise To set you up for success in this role from day one, Vyaire is looking for candidates who have the following required qualifications: Minimum BS degree in Electrical/Mechanical/Computer Science or Software related major 10 years of related test experience Additional qualifications that could help you succeed even further in this role include: Demonstrated experience in verification testing of microprocessor/software controlled medical devices of high level complexity and sophistication Able to work well with global teams, including time-zone flexibility An understanding of the Vyaire QMS in particular medical device design controls, and verification process Proficient in MS Office, and data analysis using spreadsheets. Must be detail oriented with strong data analytic, written and oral communication skills. Ability to read and understand ventilator and respiratory devices architectural, user documentation, specifications, and interpret system diagrams, schematics and technical performance specifications Able to understand ventilator system technical architecture, engineering fundamentals, including electromechanical, microprocessor, and software driven components and operation Able to work as part of an interdisciplinary team, but be self-motivated and be able to self-prioritize critical tasks Demonstrate basic understanding of IEC/ISO and FDA compliance standards pertaining to critical care medical devices, basic safety, EMC, patient monitoring sensors, alarms, and biocompatibility Basic understanding of the FDA 510(k) and PMA process, MDD, MDR and Vyaire QMS. Experience with medical device DHF, risk analysis, requirements traceability, and test method validation is a plus. Solid understanding or experience with LabVIEW based ventilator test tools, analytical tools, and automated ventilator test systems are a plus. Travel: May include up to [0%][domestic/international] Relocation Assistance: May be authorized Benefit elections are among the most meaningful choices that we make for ourselves and our family. That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees. Base range in California for the Senior Principal Test Engineer position is $142,600- $213,900. Additional benefits offered include medical, dental, vision, paid leaves, life insurance, 401k, paid time off, paid holidays and potential for tuition reimbursement. Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Irvine, CA Full time We aspire to a “higher calling”, aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices. Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories. We are transforming the future of respiratory care; explore how you can be a part of it. We are a unified “breathing company”, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to “do the right thing” every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day. One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic. To learn about our terms of use, please review Terms & Conditions. Also, provided here is a link to our Privacy Policy

Salary : $142,600 - $213,900