Sr. SW Systems Engineer

Requisition ID:  33677  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

 

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

JOB TITLE Senior Software Systems Engineer

 

JOB SUMMARY

Responsible for software product definition and translation of  users’ needs, commercial desires, regulatory and technical standards into use cases, workflows, user stories, UI mockups, and software specifications for software development teams. This role is accountable for developing clear, concise software requirements for complex medical devices and their associated software applications. This role must understand the goals of the end user and develop in-depth product expertise, both from the user and technical perspectives. Working in a regulated industry, this role must adhere to design controls procedures and help teams to execute software development while generating evidence needed for regulatory submissions/audits. This role will work with cross-functional teams to make trade-off decisions between development effort, required functionality, and end user experience.

 

ESSENTIAL DUTIES

 

This role is responsible for the following as they relate to complex medical devices and their associated software applications:

• Develop clear, concise software requirements, behavior, and feature definition
• Participate in software planning and estimation
• Requirements allocation and traceability
• Software integration strategy and planning

Project:

• Lead complex programs consisting of several software development teams including global partner teams with limited oversight.
• Define software behavior (requirements, environment, performance, etc.) medical devices using a hybrid Waterfall-Scrum software development methodology, balancing structured planning with iterative development to meet project timelines while ensuring adherence to quality standards and customer requirements.
• Gather and prioritize scope inputs from diverse stakeholders including Business Area Leaders, Platform Tech Leads, Systems Engineering, Innovation, Software Development, Marketing, and Cybersecurity Teams. Define system behavior, use environment, requirements, feature definition, use case scenarios, full error paths, corner cases, and design constraints to ensure comprehensive project scope and functionality that meets customer needs.
• Collaborate effectively with multidisciplinary teams (systems engineering, software engineering, marketing, commercialization, regulatory affairs, quality assurance) to achieve customer requirements, design control objectives, and regulatory standards.
• Determine and enforce high level ordering of activities and feature sets to deliver project scope subsets to the software development teams.
• Obtain formal cross-functional agreement of scope and priority of each project scope subset prior to starting software design and development.
• Manage scope changes throughout the project lifecycle. For mid-project requirements changes, lead and conduct impact assessments on the requirements; requirement allocation; integration strategy; and project impacts. Participate in impact assessments on the requirements flow; verification strategy, plan or protocols; and e