Principal Systems Engineer - Software

The Principal System Engineer - Software 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 broad aspects of product definition and exert influence on the development and verification of complex electro-mechanical software-controlled medical devices. 
• Work with other Systems Engineers to translate user needs into detailed product-level requirements, architectures and interfaces. 
• Work closely with Software Engineering team to influence the generation of software architectures, requirements, risk analyses. 
• Participate and influence planning of development activities (sprints), integration activities, verification strategies, and regulatory submission strategies with focus on product software. 
• Identify requirements for compliance with relevant standards and guidance documents for the development of software in medical devices. 
• Solve complex system problems by analyzing critical factors and recommending solutions and strategies. 
• Work with internal and external resources to assess Cybersecurity requirements for Third Pole products. 
• Guide and participate with software team in completion of software risk analyses with respect to user needs and intended use. Conduct benefit-risk analysis as appropriate. 
• Lead and participate in software and systems integration activities. 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 design verification, and aid in the interpretation and analysis of test data. 
• Support definition and implementation of software-based manufacturing tools. 
• 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. 

 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 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 can think 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.

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.