Principal Systems Engineer

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 Principal System Engineer is responsible for leading the system level activities for defining and developing our next generation life-saving cardiopulmonary devices. In this role, you will be directly responsible for transforming customer needs and requirements into product level requirements and architectures including all aspects of risk management as well as collaborating with a multi-disciplinary team to ensure the effective realization of those elements in the detailed designs, V&V plans and regulatory elements.  

Responsibilities: 

• Lead top-level product definition, influence the product development, and contribute heavily to the verification of complex software-controlled medical devices. 
• Collaborate with Marketing and Human Factors experts to define User Needs, requirements, and task analysis. 
• Work with interdisciplinary team to translate user needs into detailed product requirements, sub-system requirements, architectures and system interfaces. 
• Define and implement systems engineering process. 
• Conduct General Safety and Performance Requirements analysis, establish Essential Performance, as well as identify relevant standards and applicable Regulatory guidance. 
• Plan and drive the risk management process towards identification of harms and hazards, as well as performing top down and bottom up risk analyses. Conduct benefit-risk analysis as appropriate. 
• Conduct systems level prototyping, modeling, and simulations to drive effective architectural decisions. Perform tradeoff analysis and propose potential implementations. 
• Oversee execution of integration activities in partnership with system integration, software, electrical and mechanical engineering disciplines. 
• Enable the development of working solutions while balancing competing requirements. Provide a framework for evaluation and refinement of design implementation through the development cycle. 
• Guide team in the generation of test tools and methods for verification. 
• Support definition and implementation of manufacturing tools including component and system calibration, as well as product acceptance. 
• Support the verification team, aid in the interpretation and analysis of test data. 
• Solve complex system problems by analyzing critical factors and recommending solutions and strategies. 
• Participate in defect management activities as Subject Matter Expert, drive towards effective resolution strategies. 
• Establish relational linkages through the hierarchy of inputs, outputs, risks, and verification entities. Produce traceability matrices from Third Pole’s application lifecycle management databases. 
• Generate and release documents into project design history files via Third Pole’s design control and document management system. 
• Prepare and conduct technical design reviews and present effectively across all levels of the organization. 
• Develop and execute test protocols as needed 

Requirements: 

• Bachelor’s Degree in a relevant engineering discipline. Graduate degree preferred. Background in software development a plus. 
• 10 years systems engineering experience in the design and development of complex, software driven electromechanical Class II medical devices; Class III experience preferred. 
• Detailed knowledge of key regulatory requirements included ISO 14971, ISO 62304, IEC 60601, IEC 62366 as well as FDA QSR 21 CFR Part 820. 
• Experience with electronic design control and document management systems 
• Ability to work independently with high competency and little guidance 
• Must be a creative problem solver that thinks outside of the box to develop novel solutions to complex problems. 
• Strong design control and documentation skills. 
• Strong analytical and leadership skills. 

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.