Staff Software Systems Analyst (REMOTE)

The Staff Software Systems Analyst is part of a team that designs, develops, tests, and commercializes complex software and digitally connected systems focused on patient safety and clinical workflow. Specifically, you will be responsible for system definition (user needs, system requirements, system architecture, and decomposition to application and reporting/analytics software user stories), risk analysis, verification, validation, and system traceability. You will be the interface between software development scrum teams and R&D, commercial, UX, quality, and external partners to ensure the product developed meets the end user needs. You will have a focus on usability to include supporting various user studies and incorporating usability and user risk into system definition and design. Finally, you will be an authority on digitally connected medical systems and medical software product development, and will provide leadership and mentorship for other team members.

Key responsibilities will include:

• With minimal direction, lead and gain cross-functional alignment on digital systems design, definition, integration, and testing effort, provide advanced engineering skills, technology development, and product evaluation support
  

• Plan, implement, monitor, and deliver designated tasks and deliverables.
  

• Author, maintain, and gain alignment and approval on user needs, use case and workflow, system requirements and epics/features/user stories, system architecture, system risk assessment, interface definition, verification and validation plans and protocols, and other design work to support successful product development and launch
  

• Lead multi-functional teams to develop use cases and use risk analysis and ensure incorporation into system definition (user stories and risk analysis) and design
  

• Create solutions for technical problems using systematic problem-solving methodologies.
  

• Participate in and lead periodic design reviews of projects
  

• Maintain an overview of relevant technologies and products and conduct hands-on evaluation of competitive products
  

• Develop an understanding of internal and external customer needs and processes to ensure relevant and innovative solutions
  

• Ensure compliance with internal quality policies, procedures, and practices, as well as international standards and laws through appropriate communication, training, and education of sound quality assurance principles
  

Qualifications:

• BS in Software Engineering, Systems Engineering, Biomedical Engineering, Data Science, Computer Engineering, Electrical Engineering, or equivalent
  

• 7 -10 years experience with the definition and development of digitally connected complex systems, preferably in a medical device or other regulated industry
  

• Proficiency in development of user needs, product requirements, epics/features/user stories, interface requirements, risk assessments, trace reports, verification and validation plans, protocols, and reports for digitally connected medical systems
  

• Experience with app and data analytics/reporting platform systems
  

• Experience driving systems development and integration workstreams to completion
  

• Previous experience mentoring and leading others in new streamlined ways of working in new product development
  

• Experience in innovative new-to-world product definition and refinement desired
  

• Exposure to human factors engineering (preferably in the medical space) including user studies and usability documentation
  

• Development and execution of system verification and validation activities
  

• Expertise in common risk management techniques (SHA, FMEA, SRA)
  

• Experience in Agile processes as well as Phase-Gated product development, supporting complex digital medical technology development
  

• Proven experience solving technical problems and leading teams in a systematic process to resolve issues.
  

• Working knowledge of international standards applicable to medical software systems, including ISO13485, ISO14971, IEC62304, IEC62366, and its collateral standards