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 Systems Test Engineer will apply their testing experience to ensure Third Pole’s medical devices are safe and effective. This position will work cross-functionally with R&D Engineering (Systems, Mechanical, Electrical, Software, Core Technology). You will play a key role in the achievement of product performance and quality.

Responsibilities:

• Work closely with development engineers to ensure system level and sub-system level requirements are appropriately defined and testable as written.
• Establish test strategies, own or participate in generation test plans and ensure requirements are logically grouped in test protocols.
• Determine sample sizes with respect to target confidence and reliability levels that demonstrate effective mitigation of risk associated with the requirements.
• Utilize test management tools to generate detailed test protocols that fully describe acceptance criteria, testing steps and methodology to fully verify each requirement.
• Design, develop, and qualify test methods, software tools and fixtures for in-house/internal product performance testing.
• Setup and operate lab equipment for control and measurement of product performance, including use of sensors, mass flow controllers, pumps, gas concentration monitors and oscilloscopes.
• Train to internal lab safety methods, including safe set-up and operation of pressurized air and gas sources and gas exhaust evacuation.
• Identify and develop relationships with suppliers to support external testing activities such as biocompatibility and electro-magnetic compatibility.
• Manage and document test article configuration history through pre-verification and verification efforts.
• Support development effort by providing test support at integration, dry-running and formal verification stages of product development.
• Execute tests and capture test results, observations and deviations per good documentation practices.
• Perform analysis of collected data, including application of inferential statistics (t-test, z-test, distribution, tolerance interval).
• Identify, describe and address product defects as well as participate in defect management effort.
• Generate detailed matrices that capture the traceability of each requirement through test protocols and reports.

Requirements:

• Bachelor’s degree in engineering or related field
• 5+ years of experience in product development, manufacturing or quality environment where testing and verification of medical devices are a primary function
• Experience working on complex electro-mechanical and pneumatic assemblies preferred
• Expertise in the use of measurement instrumentation with data logging interfaces
• Self-starter, ability to solve problems independently
• Ability to properly document verification activities in a regulated environment
• Proficiency with MS Office applications (Excel, Word, PowerPoint, Visio)
• Experience with analytical and statistical tools such as Minitab
• Experience with test management tools (for example: Doors, Helix, Jama, etc.)

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 Accommodation

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.