Principal Systems Engineer

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:

• Collaborate with Marketing to define user needs, requirements, and task analysis
• Work with interdisciplinary team to translate user needs into detailed product requirements, architectures, subsystem designs and interfaces and V&V plans, approaches and protocols
• Drive the risk management process including Harms, Hazard and Failure Mode and Effects Analysis
• Document system design inputs and outputs using the Third Pole design control and document management system
• Follow and improve Third Pole’s procedures related to product development and design control
• Ownership of the Essential Requirements Checklist and definition of Essential Performance statements
• Collaborate with Regulatory Team to ensure regulatory requirements are effectively identified, traced into product level requirements and risk-based tradeoffs made as appropriate
• Collaborate with Test Team to ensure effective system and subsystem level integration, verification and testing activities.
• Conduct systems level prototyping, modelling, and simulations in order to drive effective architectural decisions focused on tradeoff analysis and ability for proposed approaches to effectively meet system requirements
• Lead integration effort in partnership with software, electrical and mechanical engineering disciplines, enabling the development of working solutions while balancing competing constraints.
• Solve complex system problems by analyzing critical factors and recommending corrective or alternative actions
• Perform statistical analysis of experimental results and present them in the context of meeting requirements
• Prepare and conduct technical design reviews and present effectively across all levels of the organization.

Requirements:

•  Bachelor’s Degree in engineering or related science. Electrical engineering discipline preferred. Master’s degree preferred.
• 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 preferred
• 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
• Must be able to work in a fast paced, high energy, collaborative team that possesses a strong sense of urgency
• 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.

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.