Third Pole Therapeutics

Third Pole is on a mission to expand the lifesaving benefits of Nitric Oxide inhalation therapy, making it accessible to millions of respiratory challenged newborns and adults around the world. This is a rare opportunity to be part of a rapidly growing team, making a huge social impact, touching the lives of those we love and care about most.

We are a fast-paced startup developing a game-changing technology that generates Nitric Oxide on demand, at the patient location, from the air we breathe. Our Third Pole community is grounded in the values of collaboration, embracing diverse ideas, commitment, and transparency without the politics found in most companies. Our motto is we are only successful if we all cross the finish line together! Sound like you?

The Senior Software Verification & Validation Engineer is responsible for the preparation, execution, and documentation of testing activities in support of new product introductions. Starting from a database of requirements that encompasses the Third Pole product platforms, the Senior Software Verification & Validation Engineer will develop test methods, fixtures, and procedures to first characterize and subsequently formally verify product functionality. Testing will be conducted at all levels, from component to sub-assembly to full system, and includes verification of performance and validation of user requirements. The Software Verification & Validation Engineer owns formal verification activities including planning, protocol development, test execution, data analysis and report generation. 

Responsibilities: 

• Write detailed test procedures that evaluate software and systems against documented software requirements
• Develop test methods, test scripts, and fixtures for all development testing including verification while collaborating with software development teams or outside resources
• Define, document, and continuously improve verification tests - conduct peer reviews and maintain traceability to requirements in our systems
• Execute the verification and validation of product design including requirements analysis, traceability, and testability assessment
• Prepare and execute test method and fixture qualifications. Fixtures may be mechanical, electromechanical, pneumatic, with or without software controls
• Support completion of traceability of requirements through verification and validation reports
• Maintain and control test execution records using good lab practices
• Automate tests where applicable
• Escalate, when appropriate, cross-functional support issues on projects to the Project Manager or to functional leadership
• Actively evaluate projects for opportunities to improve performance
• Continuously monitor risk and mitigate as appropriate

Requirements:

• Bachelors degree in Engineering or related field
• 4+ years of experience conducting verification and validation of electro/mechanical systems in the medical device industry
• Hands-on Software/Network testing experience for medical devices, especially for control and communication protocols
• Ability to create and use test scripts to create and run automation tests for software testing activities
• Medical device development experience along with a solid working knowledge of FDA Quality System Regulations and ISO 13485, and IEC 60601 is highly preferred
• Possess the ability to analyze requirements and develop a risk-based approach to testing
• Familiarity with requirement management tools leading to generation of complete traceability matrices (i.e., Doors, Jama, Test Track, etc.)
• Knowledge of statistical techniques for experimental design and data analyses
• Strong design control and documentation skills
• Good technical writing skills, including development of test methods, protocols, reports
• Proficient computer skills with applicable software packages (e.g., Microsoft Office, Microsoft Project, Microsoft Power Point, JIRA, etc.) and test data analysis software packages (JMP, Minitab, ReliaSoft, and/or Python)
• Good communication skills; contributing to the test sprints

Equal Opportunity Employer

Third Pole, Inc. provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

Reasonable Accommodations

The job summary, responsibilities and requirements listed above are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the responsibilities and skills required of this position. Reasonable accommodations may be made for any part of the application or interview process, and to enable qualified individuals with a medical condition or disability to perform the essential functions.