Systems Engineer III

The Opportunity:

Our team is developing new and innovative medical devices.  We are forging into new ground in exciting ways.  This group is pivotal in driving these new products to market, driving requirements and scope to make this the best product possible.  Under general supervision, responsible for designing new products and processes with future maintaining and improving existing products.

What you will do:

·       May assist the technical product owner to refine product definition, requirements, and other technical inputs to project teams developing device products and digital services.   

·       Participate in system level design documentation and requirements specification with marketing, engineering, and other stakeholders.   Assist with product definition, system or subsystem architecture, requirements writing, requirements analysis, requirements management, safety risk analysis, cybersecurity risk analysis, product testing (including V&V), and design control and regulatory documentation activities.

·       Participate in the development and maintenance of integrated system model for the system of interest using Model Based Systems Engineering (MBSE) methodology and tools. 

·       Participate in and assist with characterization of subsystem level entities of a complex system; collect, organize, analyze, and document test results.  Characterization problems may include, but not limited to, specialized technical domains such as algorithm development, human factors engineering, chemical process development, cybersecurity risk management, big data analytics, and machine learning. 

·       Participate in the integration of analytical, functional, and performance related elements with software and hardware components.  

·       Collaborate intensely with engineering and development team members to tackle product or process issues throughout the development lifecycle.  Communicate effectively throughout all levels of the cross functional development team. 

·       Plan and manage individual project deliverables and work items, their upstream dependencies, and their downstream impacts in order to meet project timeline and commitment.   

·       Act in accordance with quality system processes.  Support activities to maintain and improve quality system processes throughout the product development lifecyle. 

Required Qualifications:

·       BS in engineering or physical science or related field or equivalent. MS degree ideal.  2 yrs relevant experience in engineering or physical science.

·       Experience in Agile software development process a plus.  Proficiency in JIRA and DOORS (9.6 and/or DNG) a plus. 

·       Experience in SysML, Model Based Systems Engineering (MBSE) methodology, and system modeling tools, a plus. 

·       Experience and knowledge of defined development process that is consistent with ISO, MDR, FDA design control standards a plus.