Medical Device Senior Principal Test Engineer – Ventilation
Job Description
Full Job Description
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).
If you require alternative methods of application or screening, you must approach the employer directly to request this as H1BVisaJobs is not responsible for the employer’s application process.